Cleared Traditional

K003949 - TACKER

K003949 is the FDA 510(k) clearance for TACKER by A & A Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCW) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K003949 · A & A Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2001
Decision
216d
Days
Class 2
Risk

K003949 is an FDA 510(k) clearance for the TACKER, MODEL R65-933. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on July 25, 2001 after a review of 216 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 A & A Medical, Inc. devices

Submission Details

510(k) Number K003949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2000
Decision Date July 25, 2001
Days to Decision 216 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 130d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
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 - OCW Endoscopic Tissue Approximation Device

All 38
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K003949.
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
K062244 · Arthrocare Corp. · Oct 2006
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
K061770 · Ethicon Endo-Surgery, Inc. · Sep 2006
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269 · Ethicon Endo-Surgery, Inc. · Dec 2003
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
K002398 · Ethicon Endo-Surgery, Inc. · Nov 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
K000717 · Smith & Nephew, Inc. · Mar 2000
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
K980815 · Ethicon Endo-Surgery, Inc. · May 1998