The following data is part of a premarket notification filed by Endo-therapeutics, Inc. with the FDA for Multi-bite Hot Biopsy Forceps.
| Device ID | K090796 |
| 510k Number | K090796 |
| Device Name: | MULTI-BITE HOT BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Electric |
| Applicant | ENDO-THERAPEUTICS, INC. 15251 ROOSEVELT BLVD. SUITE 204 Clearwater, FL 33760 |
| Contact | Mark R Waddell |
| Correspondent | Mark R Waddell ENDO-THERAPEUTICS, INC. 15251 ROOSEVELT BLVD. SUITE 204 Clearwater, FL 33760 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-24 |
| Decision Date | 2009-11-25 |