Cleared Traditional

K901429 - SOFT

K901429 is an FDA 510(k) clearance for SOFT, manufactured by Telemed Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCY cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K901429 · Telemed Systems, Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
71d
Days
Class 2
Risk

K901429 is an FDA 510(k) clearance for the SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Telemed Systems, Inc. (Hudson, US). The FDA issued a Cleared decision on June 5, 1990 after a review of 71 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 Telemed Systems, Inc. devices

FDA 510(k) Submission Details - K901429

510(k) Number K901429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date June 05, 1990
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCY Device Classification - Class 2, Special Controls

Product Code OCY Endoscopic Guidewire, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories.
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 - OCY Endoscopic Guidewire, Gastroenterology-urology

All 27
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K901429.
MICROVASIVE INSURG GEENEN CBD GUIDE WIRE
K931650 · Boston Scientific Corp · Jun 1993
WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE
K910497 · Wilson-Cook Medical, Inc. · Apr 1991
450CM GUIDE WIRE FOR G.I. USE
K910722 · Terumo Corp. · Mar 1991
MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177
K892648 · Boston Scientific Corp · May 1989
GUIDE WIRE
K813026 · Inmed Corp. · Nov 1981