Cleared Traditional

K883093 - TRANSENDOSCOPIC ASPIRATION NEEDLE

K883093 is an FDA 510(k) clearance for TRANSENDOSCOPIC ASPIRATION NEEDLE, manufactured by Endovations. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K883093 · Endovations · Gastroenterology & Urology device
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Dec 1988
Decision
139d
Days
Class 2
Risk

K883093 is an FDA 510(k) clearance for the TRANSENDOSCOPIC ASPIRATION NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Endovations (Camp Hill, US). The FDA issued a Cleared decision on December 8, 1988 after a review of 139 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Endovations devices

FDA 510(k) Submission Details - K883093

510(k) Number K883093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1988
Decision Date December 08, 1988
Days to Decision 139 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 131d · This submission: 139d
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 70
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K883093.
TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE
K901437 · Telemed Systems, Inc. · Jun 1990
PORGES SCLEROTHERAPY NEEDLES
K896424 · Porges Corp. · Jan 1990
WILTEK VARICES INJECTION NEEDLE
K894868 · Wiltek Medical, Inc. · Dec 1989
WASHING/INJECTION NEEDLE
K872060 · Endovations · Jul 1987
WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE
K865086 · Van-Tec, Inc. · Mar 1987
VARICES INJECTOR
K851952 · Wilson-Cook Medical, Inc. · Jul 1985