Apyx
Escala Medical
ESCALA MEDICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3024820202 | 3024820202 | ESCALA MEDICAL | 1 | N | 2026-01-01 | 17 Tchelet st. Business Park Misgav Northern IL 2017400 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 310422 | 1421859527 | K230730 | Apyx | PBQ | 2023-07-25 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PBQ | 1 | 2023-07-25 |
PMN#
Apyx
Escala Medical
GUDID#
Mendit securement element set - Mendit securement element set contain two stainless steel securement element accessories
2026-03-10
Mendit Single Applicator Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Single Applicator Set comprises one Applicator Cartridge, with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2026-03-10
Mendit Single Applicator Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Single ApplicatorSet comprises one Applicator Cartridge, with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2026-03-10
Mendit Retriver Universal Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Retriver Universal Set comprises one Retriever Cartridge, and suture passer accessory.The Retriever Cartridge operated by the Handle is used to retrieve the anchor-suture assembly after it has been placed on ligament.
2026-03-10
Mendit Single Applicator Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Single Applicator Set comprises one Applicator Cartridge, with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2026-03-10
Mendit Single Applicator Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Single Applicator Set comprises one Applicator Cartridge, with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2026-03-10
Mendit Single Applicator Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Single Applicator Set comprises one Applicator Cartridge, with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2026-03-10
Mendit Single Applicator Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Single Applicator Set comprises one Applicator Cartridge, with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2026-03-10
Mendit Reload Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Reload Set comprises two Applicator Cartridges, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2023-06-25
Mendit Reload Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Reload Set comprises two Applicator Cartridges, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2023-10-23
Mendit Reload Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Reload Set comprises two Applicator Cartridges, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2023-10-23
Mendit Reload Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Reload Set comprises two Applicator Cartridges, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2024-06-05
Mendit Reload Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Reload Set comprises two Applicator Cartridges, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2024-06-05
Mendit Reload Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Reload Set comprises two Applicator Cartridges, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2024-06-05
Mendit Reload Set - The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Reload Set comprises two Applicator Cartridges, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2024-06-05
Mendit Retriever Set - Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly.
2024-06-05
Mendit Retriever Set - Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly.
2024-06-05
Mendit Retriever Set - Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly.
2024-06-05
Mendit Retriever Set - Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly.
2024-06-05
Mendit Applicator Set - The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the deployment and attachment of the pre-loaded anchor- suture unit at the designated position on ligament.
2024-06-05
Mendit Applicator Set - The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the deployment and attachment of the pre-loaded anchor- suture unit at the designated position on ligament.
2024-06-05
Mendit Applicator Set - The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the deployment and attachment of the pre-loaded anchor- suture unit at the designated position on ligament.
2024-06-05
Mendit applicator set - The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the deployment and attachment of the pre-loaded anchor- suture unit at the designated position on ligament.
2024-06-05
Mendit Retriever Set - The Retriever is an accessory tool allowing the retrieval of the Anchor-Suture implant from the deployment site during the index procedure. Its use is optional, and intended only in cases when retrieval of the implant is deemed necessary by the operating surgeon due to a sub-optimal placement. Using the Retriever is possible once the implant has been deployed, and before the attached suture tails are cut. Retrieving an implant does not require making an incision in the tissue or the ligament it was introduced to.
2023-10-23
Mendit Applicator Set - The Mendit is a single use repair system which enables anchoring of sutures to ligaments of the pelvic floor.The Mendit device comprises the following elements: Applicator – a delivery system comprising Applicator Cartridge and Handle, an Anchor-Suture unit (pre-loaded in the Applicator Cartridge), a Securement Element for optional use and Retriever – an accessory tool comprising of Retriever Cartridge and Handle.The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2023-10-23
Mendit Retriever Set - The Retriever is an accessory tool allowing the retrieval of the Anchor-Suture implant from the deployment site during the index procedure. Its use is optional, and intended only in cases when retrieval of the implant is deemed necessary by the operating surgeon due to a sub-optimal placement. Using the Retriever is possible once the implant has been deployed, and before the attached suture tails are cut. Retrieving an implant does not require making an incision in the tissue or the ligament it was introduced to.
2023-10-23
Mendit Applicator Set - The Mendit is a single use repair system which enables anchoring of sutures to ligaments of the pelvic floor.The Mendit device comprises the following elements: Applicator – a delivery system comprising Applicator Cartridge and Handle, an Anchor-Suture unit (pre-loaded in the Applicator Cartridge), a Securement Element for optional use and Retriever – an accessory tool comprising of Retriever Cartridge and Handle.The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2023-10-23
APYX Applicator Set - The Apyx is a single use repair system which enables anchoring of sutures to ligaments of the pelvic floor.The Apyx device comprises the following elements: Applicator – a delivery system comprising Applicator Cartridge and Handle, an Anchor-Suture unit (pre-loaded in the Applicator Cartridge), a Securement Element for optional use and Retriever – an accessory tool comprising of Retriever Cartridge and Handle.The Apyx is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2023-08-06
APYX Retriever Set - The Retriever is an accessory tool allowing the retrieval of the Anchor-Suture implant from the deployment site during the index procedure. Its use is optional, and intended only in cases when retrieval of the implant is deemed necessary by the operating surgeon due to a sub-optimal placement. Using the Retriever is possible once the implant has been deployed, and before the attached suture tails are cut. Retrieving an implant does not require making an incision in the tissue or the ligament it was introduced to.
2022-11-06
APYX Applicator Set - The Apyx is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor.The Apyx device comprises the following elements: Applicator – a delivery system comprising Applicator Cartridge and Handle, an Anchor-Suture unit (pre-loaded in the Applicator Cartridge), and Retriever – an accessory tool comprising of Retriever Cartridge and Handle.The Apyx is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
2022-11-03