Cleared Traditional

K983296 - AUTO SUTURE ABBI SYSTEM

K983296 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 256-day FDA review.

K983296 · United States Surgical, A Division of Tyco Healthc · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
256d
Days
Class 2
Risk

K983296 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 June 4, 1999 after a review of 256 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K983296

510(k) Number K983296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1998
Decision Date June 04, 1999
Days to Decision 256 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
125d slower than avg
Panel avg: 131d · This submission: 256d
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 K983296.
GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
K992499 · Gallini U.S., LLC · Aug 1999
DAUM MRI/CONVENTIONAL BIOPSY KIT
K991366 · Daum GmbH · Jun 1999
FUJI CATHETER, MODEL CTH001
K983867 · Windy Hill Technology, Inc. · Jun 1999
TRU-CORE I REUSABLE BIOPSY INSTRUMENT
K990839 · Medical Device Technologies, Inc. · May 1999
GALLINI ATRA-CUT NEEDLE
K990645 · Gallini U.S., LLC · May 1999
GALLINI BYCUT NEEDLE
K990716 · Gallini U.S., LLC · May 1999