The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Acufex Double Armed Suture Needle.
| Device ID | K970416 |
| 510k Number | K970416 |
| Device Name: | ACUFEX DOUBLE ARMED SUTURE NEEDLE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Susan A Finneran |
| Correspondent | Susan A Finneran SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-04 |
| Decision Date | 1997-04-21 |
| Summary: | summary |