FORCE 2

Electrocautery, Gynecologic (and Accessories)

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Force 2.

Pre-market Notification Details

• Device ID: K921884
• 510k Number: K921884
• Device Name: FORCE 2
• 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: 1992-04-21
• Decision Date: 1992-12-15