UNIGRIP

Laparoscope, General & Plastic Surgery

UNISURGE, INC.

The following data is part of a premarket notification filed by Unisurge, Inc. with the FDA for Unigrip.

Pre-market Notification Details

• Device ID: K943502
• 510k Number: K943502
• Device Name: UNIGRIP
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: UNISURGE, INC. 10231 BUBB RD. Cupertino, CA 95014
• Contact: Donald V Johnson
• Correspondent: Donald V Johnson; UNISURGE, INC. 10231 BUBB RD. Cupertino, CA 95014
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-06
• Decision Date: 1994-10-07