KOH MICRO-SUTURING INSTRUMENTS
FDA 510(k) clearance K955479 · decided 1995-12-08
Clearance details
- K-number
- K955479
- Device name
- KOH MICRO-SUTURING INSTRUMENTS
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-30
- Decision date
- 1995-12-08
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- OCW
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Endomina EZFuse system (K252400) | Endo Tools Therapeutics S.A. | 2026-02-13 |
| SimpleStitch Suturing System (K243750) | Envision Endoscopy | 2025-04-17 |
| MaxTack™ Motorized Fixation Device (K231240) | Covidien | 2023-09-08 |
| MedicloseTM System (K213271) | Health Value Creation B.V., Trading AS Corporis Medical | 2023-08-31 |
| OverStitch NXT Endoscopic Suturing System (K231553) | Apollo Endosurgery, Inc. | 2023-06-29 |
| endomina system (K211309) | Endo Tools Therapeutics S.A. | 2021-12-07 |
| Su2ura Approximation Device (K201744) | Anchora Medical, Ltd. | 2021-06-17 |
| OverStitch Sx Endoscopic Suturing System (K210266) | Apollo Endosurgery, Inc. | 2021-03-02 |
| AbClose - Port Site Closure Device (K193652) | Medeon Biodesign, Inc. | 2020-03-26 |
| OverStitch 2-0 Polypropylene Suture (K191439) | Apollo Endosurgery | 2019-08-29 |
| OverStitch Endoscopic Suturing System and Accessories (K181141) | Apollo Endosurgery | 2018-06-27 |
| MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle (K172775) | Teleflexmedical, Inc. | 2018-02-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |