510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K963825Substantially Equivalent

Auto Suture* Abbi* System

United States Surgical, A Division of Tyco Healthc, Norwalk CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963825 is the FDA 510(k) clearance record for AUTO SUTURE* ABBI* SYSTEM, a class II device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code KNW (Instrument, Biopsy). FDA records list 218 510(k) clearances for United States Surgical, A Division of Tyco Healthc, from to . As of , FDA records show no recalls naming K963825.

Clearance record

Decision date
Received
(87 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Surgical, A Division of Tyco Healthc 150 Glover Ave., Norwalk CT
510(k) summary
Summary
Third party review
No

Clearances, product code KNW

Trailing 12 months
8 clearances under product code KNW in the twelve months to November 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260
November 20260