Cleared Traditional

K012977 - VARICES INJECTION NEEDLE

K012977 is an FDA 510(k) clearance for VARICES INJECTION NEEDLE, manufactured by Endo-Therapeutics, Inc.. 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.

K012977 · Endo-Therapeutics, Inc. · Gastroenterology & Urology device
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Nov 2001
Decision
58d
Days
Class 2
Risk

K012977 is an FDA 510(k) clearance for the VARICES INJECTION NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Endo-Therapeutics, Inc. (Safety Harbor, US). The FDA issued a Cleared decision on November 2, 2001 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 Endo-Therapeutics, Inc. devices

FDA 510(k) Submission Details - K012977

510(k) Number K012977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2001
Decision Date November 02, 2001
Days to Decision 58 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
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 K012977.
TEGRESS IMPLANT NEEDLE
K050688 · C.R. Bard, Inc. · Apr 2005
ENTERYX INJECTION CATHETER
K042882 · Boston Scientific Corp · Nov 2004
COOK INJECTION NEEDLE
K022484 · Cook Urological, Inc. · Oct 2002
NEEDLE CATHETER
K961846 · Boston Scientific Corp · Jul 1996
WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
K954519 · Mill-Rose Laboratory · Dec 1995
INJECTION NEEDLE
K953338 · Boston Scientific Corp · Aug 1995