Cleared Traditional

K863957 - TUBEGRIPPER

K863957 is an FDA 510(k) clearance for TUBEGRIPPER, manufactured by Cathaid, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K863957 · Cathaid, Inc. · Gastroenterology & Urology device
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Oct 1986
Decision
14d
Days
Class 2
Risk

K863957 is an FDA 510(k) clearance for the TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cathaid, Inc. (Miami, US). The FDA issued a Cleared decision on October 24, 1986 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 - K863957

510(k) Number K863957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1986
Decision Date October 24, 1986
Days to Decision 14 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
116d faster than avg
Panel avg: 130d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K863957.
SHEATH, ENDOSCOPE
K862059 · Endovations · Nov 1986
BILIARY BALLOON CATHETER
K863571 · Uresil Corp. · Nov 1986
BARD BALLOON DILATATION SYSTEM
K863437 · C.R. Bard, Inc. · Oct 1986
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
K860990 · Endovations · May 1986
PVL-4.8-200 BALLOON STONE EXTRACTOR
K851954 · Wilson-Cook Medical, Inc. · Dec 1985
ZIMMON BILIARY STENT SET
K851962 · Wilson-Cook Medical, Inc. · Dec 1985