The following data is part of a premarket notification filed by Innerdyne Medical, Inc. with the FDA for Innerdyne Medical Laparoscopic Sphincterotomy Kit.
| Device ID | K932692 |
| 510k Number | K932692 |
| Device Name: | INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INNERDYNE MEDICAL, INC. 2665 MARINE WAY Mountain View, CA 94043 |
| Contact | Colin J Nichol |
| Correspondent | Colin J Nichol INNERDYNE MEDICAL, INC. 2665 MARINE WAY Mountain View, CA 94043 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-03 |
| Decision Date | 1993-12-27 |