Cleared Traditional

AUTO SUTURE ABBI SYSTEM (K983296) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
126d slower than avg
Panel avg: 130d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 95
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K983296.
VACORA VACUUM ASSISTED BIOPSY SYSTEM
K082681 · C.R. Bard, Inc. · Oct 2008
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
K062832 · C.R. Bard, Inc. · Oct 2006
EASY CORE DETACHABLE BIOPSY SYSTEM
K051361 · Boston Scientific Corp · Jun 2005
THE AUTO SUTURE* MIBB** SYSTEM
K973496 · United States Surgical, A Division of Tyco Healthc · Dec 1997
QUICK-CARE BIOPSY NEEDLE
K973565 · Cook, Inc. · Nov 1997
AUTO SUTURE* ABBI* SYSTEM
K963825 · United States Surgical, A Division of Tyco Healthc · Dec 1996