510(k) K211309
- Device
- Endomina System
- Applicant
- Endo Tools Therapeutics S.A.
- 510(k) number
- K211309
- Product code
- OCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-07
- Date received
- 2021-04-30
- Regulation
- 876.1500
- Classification name
- Endoscopic Tissue Approximation Device
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Marine Rouyer
- Address
- Rue Auguste Piccard 48 Charleroi BE 6041 6041
FDA Registration Numbers#
- 1018470
- 3012358417
- 3017636737
- 3015185328
- 1651252
- 3007695959
- 1219930
- 3017210488
- 3013188547
- 3014479313
- 1058584
- 9610612
- 1220477
- 3015183635
- 1218017
- 3014328942
- 1422634
- 3005099803
- 3035387162
- 3031276312
- 1721676
- 3009956343
- 9710649
- 1000121056
- 3021721805
- 3022505496
- 3021632375
- 1527736
- 2953359
- 3009380063
- 3017196117
- 9617547
- 3010202439
- 3005941719
- 3002907620
- 9612501
- 3018094310
- 2936485
- 2020550
- 1319660
- 3011137372
- 3001169357
- 3010432890
- 9681260
- 2647580
- 2245304
- 3014279513
- 3014461810
- 3010041511
- 3010383847
- 1650907
- 3005075853
Source Documents#
Other 510(k) Records For Product Code OCW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252400 | Endomina EZFuse system | Endo Tools Therapeutics S.A. | 2026-02-13 |
| K243750 | SimpleStitch Suturing System | Envision Endoscopy | 2025-04-17 |
| K231240 | MaxTack™ Motorized Fixation Device | Covidien | 2023-09-08 |
| K213271 | MedicloseTM System | Health Value Creation B.V., Trading AS Corporis Medical | 2023-08-31 |
| K231553 | OverStitch NXT Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2023-06-29 |
| K201744 | Su2ura Approximation Device | Anchora Medical, Ltd. | 2021-06-17 |
| K210266 | OverStitch Sx Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2021-03-02 |
| K193652 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2020-03-26 |
| K191439 | OverStitch 2-0 Polypropylene Suture | Apollo Endosurgery | 2019-08-29 |
| K181141 | OverStitch Endoscopic Suturing System and Accessories | Apollo Endosurgery | 2018-06-27 |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | 2018-02-12 |
| K172666 | CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor | Sutureease, Inc. | 2017-12-01 |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | 2017-11-15 |
| K160117 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2016-09-09 |
| K160149 | Miret Grasper, Alligator, Miret Grasper, Maryland | Miret Surgical, Inc. | 2016-08-30 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases