Cleared Traditional

K914496 - SCLEROTHERAPY NEEDLE

K914496 is an FDA 510(k) clearance for SCLEROTHERAPY NEEDLE, manufactured by Surgitek Medical Engineering Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K914496 · Surgitek Medical Engineering Corp. · Gastroenterology & Urology device
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Dec 1991
Decision
58d
Days
Class 2
Risk

K914496 is an FDA 510(k) clearance for the SCLEROTHERAPY NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Surgitek Medical Engineering Corp. (Racine, US). The FDA issued a Cleared decision on December 5, 1991 after a review of 58 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 Surgitek Medical Engineering Corp. devices

FDA 510(k) Submission Details - K914496

510(k) Number K914496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1991
Decision Date December 05, 1991
Days to Decision 58 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 130d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBK Device Classification - Class 2, Special Controls

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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 - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 52
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K914496.
BARD ENDOSCOPIC INJECTION SYSTEM
K933815 · C.R. Bard, Inc. · Dec 1993
COLONOSCOPIC INJECTION NEEDLE, C-323/C-325
K921800 · Mill-Rose Laboratory · Feb 1993
NEEDLE
K924102 · United States Endoscopy Group, Inc. · Nov 1992
WILSON-COOK ASPIRATION HANDLE
K903668 · Wilson-Cook Medical, Inc. · Oct 1990
NM INJECTION NEEDLES
K902736 · Olympus Corp. · Aug 1990
TRANSENDOSCOPIC ASPIRATION NEEDLE
K883093 · Endovations · Dec 1988