The following data is part of a premarket notification filed by Nusurg, Inc. with the FDA for Laparoscopic Needle Holder.
| Device ID | K924196 |
| 510k Number | K924196 |
| Device Name: | LAPAROSCOPIC NEEDLE HOLDER |
| Classification | Holder, Needle, Gastroenterologic |
| Applicant | NUSURG, INC. 7432 JAGER COURT Cincinnati, OH 45230 |
| Contact | Dennis R Lackey |
| Correspondent | Dennis R Lackey NUSURG, INC. 7432 JAGER COURT Cincinnati, OH 45230 |
| Product Code | FHQ |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1993-06-25 |