Cleared Traditional

K863958 - TUBEGRIPPER

K863958 is an FDA 510(k) clearance for TUBEGRIPPER, manufactured by Cathaid, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K863958 · Cathaid, Inc. · Gastroenterology & Urology device
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Nov 1986
Decision
25d
Days
Class 2
Risk

K863958 is an FDA 510(k) clearance for the TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Cathaid, Inc. (Miami, US). The FDA issued a Cleared decision on November 4, 1986 after a review of 25 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 Cathaid, Inc. devices

FDA 510(k) Submission Details - K863958

510(k) Number K863958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1986
Decision Date November 04, 1986
Days to Decision 25 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 130d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
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 - KOD Catheter, Urological

All 130
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K863958.
VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER
K870694 · Van-Tec, Inc. · Mar 1987
COOK-VPI INTERMITTENT CATHETER
K863082 · Cook Urological, Inc. · Nov 1986
BIO-GUARD AB COATED CATHETER
K863354 · Cook Urological, Inc. · Nov 1986
FOLEY CATHETERS
K863517 · Instrumentation Industries, Inc. · Oct 1986
MODIFIED FOLEY CATHETER
K863302 · Sheridan Catheter Corp. · Oct 1986
NORTA TEFLON COATED LATEX BALLOON CATHETERS
K861181 · Beiersdorf, Inc. · Apr 1986