SURGISTAT
Electrocautery, Gynecologic (and Accessories)
VALLEYLAB, INC.
The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Surgistat.
Pre-market Notification Details
| Device ID | K922206 |
| 510k Number | K922206 |
| Device Name: | SURGISTAT |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Peggy Walline |
| Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-12 |
| Decision Date | 1993-09-07 |
Trademark Results [SURGISTAT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGISTAT 85370470 not registered Dead/Abandoned |
Hemostasis, LLC 2011-07-13 |
 SURGISTAT 73297226 1198551 Live/Registered |
Valleylab, Inc. 1981-02-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.