Cleared Traditional

K934738 - AUTOSUTURE ENDOSCOPIC SUTURING DEVICE (FDA 510(k) Clearance)

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

K934738 · United States Surgical, A Division of Tyco Healthc · Gastroenterology & Urology device
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Mar 1994
Decision
166d
Days
Class 2
Risk

K934738 is an FDA 510(k) clearance for the AUTOSUTURE ENDOSCOPIC SUTURING DEVICE. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on March 16, 1994 after a review of 166 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K934738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1993
Decision Date March 16, 1994
Days to Decision 166 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
36d slower than avg
Panel avg: 130d · This submission: 166d
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 69
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