Cleared Traditional

K000646 - DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE

K000646 is an FDA 510(k) clearance for DISPOSABLE INJECTOR OR DISPOSABLE SCLER..., manufactured by Enteric Medical Technologies. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K000646 · Enteric Medical Technologies · Gastroenterology & Urology device
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Apr 2000
Decision
48d
Days
Class 2
Risk

K000646 is an FDA 510(k) clearance for the DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Enteric Medical Technologies (Foster City, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 48 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 Enteric Medical Technologies devices

FDA 510(k) Submission Details - K000646

510(k) Number K000646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2000
Decision Date April 13, 2000
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 131d · This submission: 48d
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 81
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K000646.
ADVANCED UROSCIENCE INNERSHEATH
K002573 · Advanced Uroscience, Inc. · Nov 2000
ADVANCED UROSCIENCE INJECTION NEEDLE
K002323 · Advanced Uroscience, Inc. · Jul 2000
GENYX FLEXIBLE INJECTION NEEEDLE
K001146 · Geny Medical, Inc. · Jun 2000
GENYX MEDICAL INJECTION NEEDLE
K990996 · Genyx Medical, Inc. · Jun 1999
INJECTION NEEDLE PROBE/DEVICE-TUNIS
K983765 · Ximed/Prosure/Injectx · Dec 1998
ADVANCED UROSCIENCE INJECTION NEEDLE
K982890 · Advanced Uroscience, Inc. · Oct 1998