Cleared Traditional

K913587 - JTECH 50 SERIES CUTTING LOOP

K913587 is an FDA 510(k) clearance for JTECH 50 SERIES CUTTING LOOP, manufactured by J-Tech, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJL cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K913587 · J-Tech, Inc. · Gastroenterology & Urology device
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Oct 1991
Decision
72d
Days
Class 2
Risk

K913587 is an FDA 510(k) clearance for the JTECH 50 SERIES CUTTING LOOP. Classified as Resectoscope (product code FJL), Class II - Special Controls.

Submitted by J-Tech, Inc. (Midvale, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 72 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 J-Tech, Inc. devices

FDA 510(k) Submission Details - K913587

510(k) Number K913587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1991
Decision Date October 23, 1991
Days to Decision 72 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
58d faster than avg
Panel avg: 130d · This submission: 72d
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 K913587.
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
TEFLON COATED RESECTOSCOPE SHEATH
K761242 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976