The following data is part of a premarket notification filed by Innovative Surgical Devices Corp. with the FDA for Herniastat.
| Device ID | K884404 |
| 510k Number | K884404 |
| Device Name: | HERNIASTAT |
| Classification | Stapler, Surgical |
| Applicant | INNOVATIVE SURGICAL DEVICES CORP. 694 MAIN ST. Westbury, NY 11590 |
| Contact | Robert R Oddsen |
| Correspondent | Robert R Oddsen INNOVATIVE SURGICAL DEVICES CORP. 694 MAIN ST. Westbury, NY 11590 |
| Product Code | GAG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-19 |
| Decision Date | 1988-11-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HERNIASTAT 74252910 not registered Dead/Abandoned |
Stryker Corporation 1992-03-06 |