GRIPPER

Laparoscope, General & Plastic Surgery

SURGICAL INSTRUMENT, INC.

The following data is part of a premarket notification filed by Surgical Instrument, Inc. with the FDA for Gripper.

Pre-market Notification Details

• Device ID: K930607
• 510k Number: K930607
• Device Name: GRIPPER
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: SURGICAL INSTRUMENT, INC. 1030 RICHFIELD RD. Placentia, CA 92670
• Contact: Don W Haar
• Correspondent: Don W Haar; SURGICAL INSTRUMENT, INC. 1030 RICHFIELD RD. Placentia, CA 92670
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-02-05
• Decision Date: 1994-02-15