The following data is part of a premarket notification filed by Uromed Corp. with the FDA for Uromed Needle Grasper.
| Device ID | K974137 |
| 510k Number | K974137 |
| Device Name: | UROMED NEEDLE GRASPER |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | UROMED CORP. 64 A ST. Needham, MA 02194 |
| Contact | Frederick Tobia |
| Correspondent | Frederick Tobia UROMED CORP. 64 A ST. Needham, MA 02194 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-03 |
| Decision Date | 1998-01-30 |
| Summary: | summary |