Cleared Traditional

K935756 - ENDOSCOPIC ARTICULATING MULTI-FEED STAP...

K935756 is the FDA 510(k) clearance for ENDOSCOPIC ARTICULATING MULTI-FEED STAP... by Ethicon Endo-Surgery, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCW) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K935756 · Ethicon Endo-Surgery, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 1994
Decision
146d
Days
Class 2
Risk

K935756 is an FDA 510(k) clearance for the ENDOSCOPIC ARTICULATING MULTI-FEED STAPLER WITH RELOAD UNIT. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 21, 1994 after a review of 146 days - within the typical 510(k) review window.

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 Ethicon Endo-Surgery, Inc. devices

Submission Details

510(k) Number K935756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1993
Decision Date April 21, 1994
Days to Decision 146 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
16d slower than avg
Panel avg: 130d · This submission: 146d
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 33
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K935756.
ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADING UNIT
K945202 · Ethicon Endo-Surgery, Inc. · Jan 1995
DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER
K944435 · Deroyal Industries, Inc. · Nov 1994
MODIFIED ENDOPATH ILS
K940967 · Ethicon Endo-Surgery, Inc. · May 1994
AUTOSUTURE ENDOSCOPIC SUTURING DEVICE
K934738 · United States Surgical, A Division of Tyco Healthc · Mar 1994
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
K934174 · Ethicon, Inc. · Mar 1994
PROXIMATE ARTICULATING LINEAR STAPLER
K932434 · Ethicon Endo-Surgery, Inc. · Feb 1994