Cleared Traditional

K934647 - KARL STORZ CUTTING LOOP ELECTRODES MODI...

K934647 is the FDA 510(k) clearance for KARL STORZ CUTTING LOOP ELECTRODES MODI... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJL) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K934647 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
133d
Days
Class 2
Risk

K934647 is an FDA 510(k) clearance for the KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION. Classified as Resectoscope (product code FJL), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 133 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 K934647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1993
Decision Date February 09, 1994
Days to Decision 133 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
3d slower than avg
Panel avg: 130d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJL Resectoscope
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 - FJL Resectoscope

All 16
Devices cleared under the same product code (FJL) and FDA review panel - the closest regulatory comparables to K934647.
KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS
K952574 · KARL STORZ Endoscopy-America, Inc. · Jul 1995
FLOVAL
K934835 · Olympus Corp. · Jun 1994
SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)
K936038 · Surgical Laser Technologies, Inc. · May 1994
RESECTOSCOPE SHEATH
K931995 · Olympus Corp. · Jul 1993
OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES
K904940 · Olympus Corp. · Jan 1992
TEFLON COATED RESECTOSCOPE SHEATH
K761242 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976