The following data is part of a premarket notification filed by Innerdyne, Inc. with the FDA for Innerdyne Step Trocar Expandable Port, Onestep.
| Device ID | K961940 |
| 510k Number | K961940 |
| Device Name: | INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Rick Gaykowski |
| Correspondent | Rick Gaykowski INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1996-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521090842 | K961940 | 000 |
| 10884521090828 | K961940 | 000 |
| 10884521090767 | K961940 | 000 |
| 10884521090705 | K961940 | 000 |
| 10884521090668 | K961940 | 000 |
| 10884521090651 | K961940 | 000 |
| 10884521090644 | K961940 | 000 |