Cleared Traditional

K945889 - KARL STORZ PLASTIC SURGERY ACCESSORIES

K945889 is the FDA 510(k) clearance for KARL STORZ PLASTIC SURGERY ACCESSORIES by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GCM) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K945889 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Mar 1995
Decision
111d
Days
Class 2
Risk

K945889 is an FDA 510(k) clearance for the KARL STORZ PLASTIC SURGERY ACCESSORIES. Classified as Endoscope, Rigid (product code GCM), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 111 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K945889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1994
Decision Date March 22, 1995
Days to Decision 111 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 130d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCM Endoscope, Rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - GCM Endoscope, Rigid

All 7
Devices cleared under the same product code (GCM) and FDA review panel - the closest regulatory comparables to K945889.
KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
K962393 · KARL STORZ Endoscopy-America, Inc. · Sep 1996
HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR
K955120 · Ethicon Endo-Surgery, Inc. · Jan 1996
ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY
K935235 · Smith & Nephew Richards, Inc. · Mar 1995
PRESSURE TURING AND ACCESSORIES
K925918 · Applied Medical Resources · Feb 1993
RIGID ENDOSCOPE
K853514 · American Edwards Laboratories · Oct 1985