The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive Devices Y-knot Suture Clip.
| Device ID | K973313 |
| 510k Number | K973313 |
| Device Name: | INNOVASIVE DEVICES Y-KNOT SUTURE CLIP |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
| Contact | Eric Bannon |
| Correspondent | Eric Bannon INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-03 |
| Decision Date | 1997-12-01 |
| Summary: | summary |