The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Zsi Loop, Zsi Ball & Zsi Needle Electrodes.
| Device ID | K925560 |
| 510k Number | K925560 |
| Device Name: | ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Trish Willging |
| Correspondent | Trish Willging ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-03 |
| Decision Date | 1994-08-30 |