Cleared Traditional

K955479 - KOH MICRO-SUTURING INSTRUMENTS

K955479 is the FDA 510(k) clearance for KOH MICRO-SUTURING INSTRUMENTS by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCW) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K955479 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Dec 1995
Decision
8d
Days
Class 2
Risk

K955479 is an FDA 510(k) clearance for the KOH MICRO-SUTURING INSTRUMENTS. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on December 8, 1995 after a review of 8 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K955479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1995
Decision Date December 08, 1995
Days to Decision 8 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
122d faster than avg
Panel avg: 130d · This submission: 8d
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 37
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K955479.
ENDOSCOPIC CLIP APPLIER
K962493 · Aesculap, Inc. · Sep 1996
ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
K961390 · Ethicon Endo-Surgery, Inc. · Jun 1996
ENDOSCOPIC NEEDLE DRIVER
K960011 · United States Surgical, A Division of Tyco Healthc · Feb 1996
ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADING UNIT
K945202 · Ethicon Endo-Surgery, Inc. · Jan 1995
ORIGIN TACKER SYSTEM
K944415 · Origin Medsystems, Inc. · Nov 1994
DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER
K944435 · Deroyal Industries, Inc. · Nov 1994