The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Biopsy Forceps, Electric.
| Device ID | K925361 |
| 510k Number | K925361 |
| Device Name: | BIOPSY FORCEPS, ELECTRIC |
| Classification | Forceps, Biopsy, Electric |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Contact | John Winstanley |
| Correspondent | John Winstanley UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-22 |
| Decision Date | 1993-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995183766 | K925361 | 000 |
| 10724995183728 | K925361 | 000 |