Cleared Traditional

DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER (K944435) - FDA 510(k) Clearance

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

K944435 · Deroyal Industries, Inc. · Gastroenterology & Urology device
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Nov 1994
Decision
64d
Days
Class 2
Risk

K944435 is an FDA 510(k) clearance for the DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on November 15, 1994 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Deroyal Industries, Inc. devices

Submission Details

510(k) Number K944435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1994
Decision Date November 15, 1994
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
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 20
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K944435.
ENDOSCOPIC CLIP APPLIER
K962493 · Aesculap, Inc. · Sep 1996
ENDOSCOPIC NEEDLE DRIVER
K960011 · United States Surgical, A Division of Tyco Healthc · Feb 1996
KOH MICRO-SUTURING INSTRUMENTS
K955479 · KARL STORZ Endoscopy-America, Inc. · Dec 1995
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
ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION
K935064 · Ethicon, Inc. · Jan 1994