AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER

Staple, Implantable

UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture Endoscopic Ta Surgical Stapler.

Pre-market Notification Details

• Device ID: K910192
• 510k Number: K910192
• Device Name: AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER
• Classification: Staple, Implantable
• Applicant: UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856
• Contact: Steve Reitzler
• Correspondent: Steve Reitzler; UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856
• Product Code: GDW
• CFR Regulation Number: 878.4750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-01-16
• Decision Date: 1991-02-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20884521047775	K910192	000
20884521047768	K910192	000
20884521047744	K910192	000
10884521047754	K910192	000