Cleared Traditional

K002778 - ENTERIC INJECTION CATHETER WITH IRRIGATION

K002778 is an FDA 510(k) clearance for ENTERIC INJECTION CATHETER WITH IRRIGATION, manufactured by Enteric Medical Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K002778 · Enteric Medical Technologies, Inc. · Gastroenterology & Urology device
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Nov 2000
Decision
77d
Days
Class 2
Risk

K002778 is an FDA 510(k) clearance for the ENTERIC INJECTION CATHETER WITH IRRIGATION. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Enteric Medical Technologies, Inc. (Foster City, US). The FDA issued a Cleared decision on November 22, 2000 after a review of 77 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, Inc. devices

FDA 510(k) Submission Details - K002778

510(k) Number K002778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2000
Decision Date November 22, 2000
Days to Decision 77 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
54d faster than avg
Panel avg: 131d · This submission: 77d
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 82
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K002778.
VARICES INJECTION NEEDLE
K012977 · Endo-Therapeutics, Inc. · Nov 2001
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
K011484 · Olympus Optical Co., Ltd. · Aug 2001
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
K010448 · Horizons Intl. Corp. · May 2001
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