Product code PBQ
- Device name
- Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Attaching suture or stapling ligaments of the pelvic floor.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260380 | Mendit | Escala Medical, Ltd. | 2026-03-04 |
| K230730 | Apyx | Escala Medical | 2023-07-25 |
| K220420 | Saffron Fixation System | Coloplast A/S | 2022-06-10 |
| K213783 | Apyx | Escala Medical | 2022-04-05 |
| K160569 | NeuGuide | Pop Medical Solutions | 2016-07-06 |
| K130059 | ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP | Ibi Israel Biomedical Innovations , Ltd. | 2013-07-29 |
| K120831 | ANCHORSURE | Neomedic International S.L. | 2012-10-12 |
| K042603 | GYNECARE PROLENE FASTENER SYSTEM | ETHICON, Inc. | 2004-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290019174219 | Mendit Single Applicator Set | ESCALA MEDICAL LTD | 2026-03-10 |
| 07290019174226 | Mendit Single Applicator Set | ESCALA MEDICAL LTD | 2026-03-10 |
| 07290019174233 | Mendit Single Applicator Set | ESCALA MEDICAL LTD | 2026-03-10 |
| 07290019174240 | Mendit Single Applicator Set | ESCALA MEDICAL LTD | 2026-03-10 |
| 07290019174257 | Mendit Retriver Universal Set | ESCALA MEDICAL LTD | 2026-03-10 |
| 07290019174431 | Mendit Single Applicator Set | ESCALA MEDICAL LTD | 2026-03-10 |
| 07290019174448 | Mendit Single Applicator Set | ESCALA MEDICAL LTD | 2026-03-10 |
| 07290019174455 | Mendit securement element set | ESCALA MEDICAL LTD | 2026-03-10 |
| 17290017082056 | EnPlace Refill Kit | FEMSELECT LTD | 2026-01-08 |
| 07290019174097 | Mendit applicator set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174202 | Mendit Retriever Set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174196 | Mendit Retriever Set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174189 | Mendit Retriever Set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174172 | Mendit Retriever Set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174165 | Mendit Reload Set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174158 | Mendit Applicator Set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174141 | Mendit Reload Set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174134 | Mendit Applicator Set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174127 | Mendit Applicator Set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174110 | Mendit Reload Set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174103 | Mendit Reload Set | ESCALA MEDICAL LTD | 2024-06-05 |
| 07290019174059 | Mendit Reload Set | ESCALA MEDICAL LTD | 2023-10-23 |
| 07290019174417 | Mendit Retriever Set | ESCALA MEDICAL LTD | 2023-10-23 |
| 07290019174400 | Mendit Applicator Set | ESCALA MEDICAL LTD | 2023-10-23 |
| 07290019174042 | Mendit Retriever Set | ESCALA MEDICAL LTD | 2023-10-23 |
| 07290019174035 | Mendit Applicator Set | ESCALA MEDICAL LTD | 2023-10-23 |
| 07290019174424 | Mendit Reload Set | ESCALA MEDICAL LTD | 2023-10-23 |
| 07290019174004 | APYX Applicator Set | ESCALA MEDICAL LTD | 2023-08-06 |
| 05708932757690 | Saffron | Coloplast A/S | 2022-09-09 |
| 07290017082028 | EnPlace | FEMSELECT LTD | 2022-06-19 |