The following data is part of a premarket notification filed by Innerdyne Medical, Inc. with the FDA for Innerdyne Step Trocar Expandable Port, S.t.e.p..
| Device ID | K940232 |
| 510k Number | K940232 |
| Device Name: | INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P. |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INNERDYNE MEDICAL, INC. 1244 REAMWOOD AVE. Sunnyvale, CA 94089 |
| Contact | Colin J Nichols |
| Correspondent | Colin J Nichols INNERDYNE MEDICAL, INC. 1244 REAMWOOD AVE. Sunnyvale, CA 94089 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-14 |
| Decision Date | 1994-04-18 |