SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)
Envision Endoscopy
ENVISION ENDOSCOPY INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3021551844 | 3021551844 | ENVISION ENDOSCOPY INC. | 1 | N | 2026-01-01 | 204 Second Ave Waltham MA US 02451 |
| 0 | 0 | ENVISION ENERGY CO., LTD | 5 | N | 2020-04-25 | No.3 Shenzhuang Road, Jiangyin Wuxi Jiangsu CN 214400 |
| 3009261582 | 3009261582 | EnvisionTEC Inc. | 1 | Y | 2020-04-25 | 15162 S Commerce Dr Dearborn MI US 48120 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 351349 | 2005049571 | K243750 | SimpleStitch Suturing System | OCW | 2025-04-17 |
| 351349 | 1915062675 | K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) | OCZ | 2024-12-20 |
| 202599 | 1619211114 | ||||
| 249132 | 1926877547 | ||||
| 202599 | 2043731527 |
Product Codes Associated With Registrations#
PMN#
Radify Triage
Envisionit Deepai, Ltd.
SmileGuard
EnvisionTEC GmbH
E-Temp
Envisiontec GmbH
E-Dent 1000
EnvisionTEC GmbH
E-Denture Pro
EnvisionTEC GmbH
E-Guard
EnvisionTEC GmbH
TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
ENVISIONEERING, LLC.
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
ENVISIONEERING, LLC.
TARGETSCAN BIOPSY KIT
Envisioneering, LLC
TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM
ENVISIONEERING, LLC.
ELRAN 01 SYSTEM
ENVISION ADVANCED MEDICAL SYSTEM LTD
3-CCD DIGITAL CAMERA
ENVISION MEDICAL CORP.
SURGICAL INTEGRATED CAMERA SYSTEM
ENVISION MEDICAL CORP.
XENON LIGHT SOURCE
ENVISION MEDICAL CORP.
ENVISION ARTHROSCOPY VISUALIZATION SYSTEM
ENVISION SURGICAL SYSTEM, INC.
ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE
ENVISION SURGICAL SYSTEM, INC.
ENVISION ARTHROSCOPY SYSTEM
ENVISION SURGICAL SYSTEM, INC.
ISOLATED CAMERA HEAD
ENVISION MEDICAL CORP.
CAMERA, SURGICAL AND ACCESSORIES
ENVISION MEDICAL CORP.
ENVISION G31 P.E. PAK
ENVISION, INC.
ENVISION G21 I/A ENPAK
ENVISION, INC.
GUDID#
SimpleStitch - Suture Cartridge
2026-07-17
SimpleStitch - Suture Cartridge
2026-07-17
SimpleStitch - Suture Cinch
2026-07-17
SimpleSnip - SC500230
2026-07-17
SimpleStitch - Suture Cinch
2026-07-17
SimpleStitch - Endoscopic Suturing System
2026-07-17
SimpleStitch - Endoscopic Suturing System
2026-07-17
SimpleStitch - Endoscopic Suturing System
2026-07-17
SimpleSnip - Endoscopic Suture Cutter
2026-07-17
E-Guard - E-Guard is a light-curing material for the additive manufacturing of individual dental bite splints.
2020-12-02
E-Guard Blue - E-Guard Blue is a light-curing material for the additive manufacturing of individual dental bite splints
2020-12-17
SmileGuard - SmileGuard is a light-curing material for the additive manufacuring of flexible, individual dental bite splints.
2022-08-19
Flexcera Base Ultra+ Dark Meharry - Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases
2023-09-13
Flexcera Base Ultra+ Light Pink - Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases
2023-09-13
Flexcera™ Base Ultra+ Dark Pink - Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases
2023-09-13
Flexcera™ Base Ultra+ Medium Pink - Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases
2023-09-13
Flexcera Base Ultra+ Pink - Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases
2023-09-13
Flexcera™ Smile Ultra+ for Carbon® Printers B1 - Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and partialcrowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2023-08-02
Flexcera™ Smile Ultra+ for Carbon® Printers A2 - Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and partialcrowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2023-08-02
Flexcera™ Smile Ultra+ for Carbon® Printers A1 - Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and partialcrowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2023-08-02
Flexcera™ Smile Ultra+ for Carbon® Printers Bleach - Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and partialcrowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2023-08-02
Flexcera™ Smile Ultra+ Bleach 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ B1 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A3.5 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A3 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A2 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A1 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ Bleach - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ B1 - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A3.5 - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A3 - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A2 - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A1 - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera Smile Bleach - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Smile B1 - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Smile A3.5 - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Smile A3 - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Smile A2 - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Smile A1 - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Base Dark Meharry - Flexcera Base is a light-curing material for the additive manufacturing of individual and removable full denture bases
2021-05-06