The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Hf-resection Electrode, Loop W/runner Endos/access.
| Device ID | K931763 |
| 510k Number | K931763 |
| Device Name: | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-08 |
| Decision Date | 1994-08-29 |