Cleared Traditional

SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) (K936038) - FDA 510(k) Clearance

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

K936038 · Surgical Laser Technologies, Inc. · Gastroenterology & Urology device
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May 1994
Decision
158d
Days
Class 2
Risk

K936038 is an FDA 510(k) clearance for the SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR). Classified as Resectoscope (product code FJL), Class II - Special Controls.

Submitted by Surgical Laser Technologies, Inc. (Oaks, US). The FDA issued a Cleared decision on May 27, 1994 after a review of 158 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 Surgical Laser Technologies, Inc. devices

Submission Details

510(k) Number K936038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date May 27, 1994
Days to Decision 158 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
28d slower than avg
Panel avg: 130d · This submission: 158d
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 15
Devices cleared under the same product code (FJL) and FDA review panel - the closest regulatory comparables to K936038.
RESECTOSCOPES
K954050 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
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
KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION
K934647 · KARL STORZ Endoscopy-America, Inc. · Feb 1994
RESECTOSCOPE SHEATH
K931995 · Olympus Corp. · Jul 1993
OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES
K904940 · Olympus Corp. · Jan 1992