Cleared Traditional

K882641 - TECNOL CATHETER LEG STRAP

K882641 is an FDA 510(k) clearance for TECNOL CATHETER LEG STRAP, manufactured by Tecnol New Jersey Wound Care, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K882641 · Tecnol New Jersey Wound Care, Inc. · Gastroenterology & Urology device
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Jul 1988
Decision
15d
Days
Class 2
Risk

K882641 is an FDA 510(k) clearance for the TECNOL CATHETER LEG STRAP. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Fort Worth, US). The FDA issued a Cleared decision on July 12, 1988 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Tecnol New Jersey Wound Care, Inc. devices

FDA 510(k) Submission Details - K882641

510(k) Number K882641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1988
Decision Date July 12, 1988
Days to Decision 15 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
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KNY Accessories, Catheter, G-u

All 23
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K882641.
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K905128 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990
CATHETER PLUG/PROTECTOR
K896806 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
DEFLECTING GUIDE WIRE
K833242 · Van-Tec, Inc. · Oct 1983
SAFEED DISP. PLASTIC CATHETER
K771212 · Terumo America, Inc. · Sep 1977
SILASTIC BRAND GASTRIC LAVAGE TUBE
K760943 · Dow Corning Corp. Healthcare Industries Materials · Nov 1976