Uromed Needle Grasper
FDA 510(k) K974137 · Uromed Corp.
510(k) numberK974137
Submission
- Device name
- Uromed Needle Grasper
- Applicant
- Uromed Corp.
Needham, MA, US - Received
- November 3, 1997
- Decision date
- January 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCW – Endoscopic Tissue Approximation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
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| K252400 | Endomina EZFuse systemOCW · Traditional | Endo Tools Therapeutics S.A. | 02/13/2026SE |
| K243750 | SimpleStitch Suturing SystemOCW · Traditional | Envision Endoscopy | 04/17/2025SE |
| K231240 | MaxTack Motorized Fixation DeviceOCW · Traditional | Covidien | 09/08/2023SE |
| K213271 | MedicloseTM SystemOCW · Traditional | Health Value Creation B.V., Trading AS Corporis… | 08/31/2023SE |
| K231553 | OverStitch NXT Endoscopic Suturing SystemOCW · Special | Apollo Endosurgery, Inc. | 06/29/2023SE |
| K211309 | endomina systemOCW · Traditional | Endo Tools Therapeutics S.A. | 12/07/2021SE |
| K201744 | Su2ura Approximation DeviceOCW · Traditional | Anchora Medical, Ltd. | 06/17/2021SE |
| K210266 | OverStitch Sx Endoscopic Suturing SystemOCW · Special | Apollo Endosurgery, Inc. | 03/02/2021SE |
| K193652 | AbClose - Port Site Closure DeviceOCW · Traditional | Medeon Biodesign, Inc. | 03/26/2020SE |
| K191439 | OverStitch 2-0 Polypropylene SutureOCW · Traditional | Apollo Endosurgery | 08/29/2019SE |
More from Apollo Endosurgery
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|---|---|---|
| K010213 | Modification to Cavermap Surgical AidETN · Traditional | 04/20/2001SE |
| K010098 | Modification to Cavermap Surgical AidFGM · Special | 02/01/2001SE |
| K000507 | Cavermap Surgical AidETN · Traditional | 04/21/2000SE |
| K993436 | Cavermap Surgical AidFGM · Traditional | 02/11/2000SE |
| K982226 | Uromed Brachytheraphy IODINE-125 SourcesKXK · Traditional | 05/13/1999SE |
| K980717 | Uromed Sling KitKNA · Traditional | 05/22/1998SE |
| K974600 | Uromed PatchMNG · Traditional | 03/31/1998SE |
| K970971 | Uro Med Nerve StimulatorETN · Traditional | 10/27/1997SE |
| K971992 | Uromed Alternative Bladder Control Continence DEVICE(ABCPN-0026)FHA · Traditional | 08/01/1997SE |
Questions and answers
When was Uromed Needle Grasper cleared by the FDA?
Uromed Needle Grasper (K974137) received a 510(k) decision of Substantially Equivalent on January 30, 1998, 88 days after the submission was received.
What is the product code of K974137?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.