Cleared Traditional

K963825 - AUTO SUTURE* ABBI* SYSTEM

K963825 is an FDA 510(k) clearance for AUTO SUTURE* ABBI* SYSTEM, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K963825 · United States Surgical, A Division of Tyco Healthc · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
87d
Days
Class 2
Risk

K963825 is an FDA 510(k) clearance for the AUTO SUTURE* ABBI* SYSTEM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on December 20, 1996 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K963825

510(k) Number K963825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1996
Decision Date December 20, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 131d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 304
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K963825.
MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
K970565 · Biopsys Medical, Inc. · Mar 1997
SURE CORE BIOPSY KIT
K963813 · Interventional Concepts, Inc. · Mar 1997
TZ
K964777 · Gallini Intl., Inc. · Jan 1997
MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA
K962969 · Medical Device Technologies, Inc. · Dec 1996
SPEED-CUT
K961407 · Gallini Intl., Inc. · Nov 1996
SKINNY,FRANSEEN,WESCOTT NEEDLES
K962907 · Baxter Healthcare Corp · Oct 1996