The following data is part of a premarket notification filed by Endo-therapeutics, Inc. with the FDA for Biopsy Forceps.
| Device ID | K925392 |
| 510k Number | K925392 |
| Device Name: | BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | ENDO-THERAPEUTICS, INC. 604-C PACKARD COURT Safety Harbor, FL 34695 |
| Contact | John G Chase |
| Correspondent | John G Chase ENDO-THERAPEUTICS, INC. 604-C PACKARD COURT Safety Harbor, FL 34695 |
| Product Code | FCL |
| Subsequent Product Code | BWH |
| Subsequent Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-26 |
| Decision Date | 1993-11-05 |