Cleared Traditional

K964892 - FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)

K964892 is an FDA 510(k) clearance for FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY), manufactured by Gynecare Innovation Center. The device is a Class 2 Gastroenterology & Urology device with product code FJL cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K964892 · Gynecare Innovation Center · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
60d
Days
Class 2
Risk

K964892 is an FDA 510(k) clearance for the FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY). Classified as Resectoscope (product code FJL), Class II - Special Controls.

Submitted by Gynecare Innovation Center (Sunnyvale, US). The FDA issued a Cleared decision on February 4, 1997 after a review of 60 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 Gynecare Innovation Center devices

FDA 510(k) Submission Details - K964892

510(k) Number K964892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1996
Decision Date February 04, 1997
Days to Decision 60 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 130d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJL Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (FJL) and FDA review panel - the closest regulatory comparables to K964892.
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
K062720 · Richard Wolf Medical Instruments Corp. · Mar 2007
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES
K042523 · Richard Wolf Medical Instruments Corp. · Mar 2005
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207
K041610 · Richard Wolf Medical Instruments Corp. · Aug 2004
KARL STORZ URETER RESECTOSCOPE
K960757 · KARL STORZ Endoscopy-America, Inc. · May 1996
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