The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Pre-tied Loop Suture Cannula.
| Device ID | K925914 |
| 510k Number | K925914 |
| Device Name: | PRE-TIED LOOP SUTURE CANNULA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | John D Paulson |
| Correspondent | John D Paulson ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-23 |
| Decision Date | 1993-05-12 |