Cleared Traditional

K943176 - KARL STORZ HOPKINS I&II/OPER/AUTOCLAVAB...

K943176 is the FDA 510(k) clearance for KARL STORZ HOPKINS I&II/OPER/AUTOCLAVAB... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAJ) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K943176 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 1994
Decision
173d
Days
Class 2
Risk

K943176 is an FDA 510(k) clearance for the KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on December 21, 1994 after a review of 173 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K943176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1994
Decision Date December 21, 1994
Days to Decision 173 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
43d slower than avg
Panel avg: 130d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAJ Cystoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FAJ Cystoscope And Accessories, Flexible/rigid

All 62
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K943176.
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
K021074 · Olympus America, Inc. · May 2002
FLEXIBLE FIBERSCOPES AND ACCESSORIES
K980401 · Richard Wolf Medical Instruments Corp. · May 1998
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
K945527 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
K941779 · KARL STORZ Endoscopy-America, Inc. · Jun 1994
KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION TELESCOPE
K935278 · KARL STORZ Endoscopy-America, Inc. · Jun 1994
BARD STABILIZING CANNULA
K930827 · C.R. Bard, Inc. · May 1993