UROMED NEEDLE GRASPER
FDA 510(k) clearance K974137 · decided 1998-01-30
Clearance details
- K-number
- K974137
- Device name
- UROMED NEEDLE GRASPER
- Applicant
- Uromed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-03
- Decision date
- 1998-01-30
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- OCW
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Needham, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Uromed Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
|---|---|---|
| RELIANCE URINARY CONTROL INSERT & SIZING DEVICE (P960020/S001) | Uromed Corp. | 1999-04-01 |
| RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE (P960020) | Uromed Corp. | 1996-08-16 |