Cleared Traditional

K993118 - BIOTEQUE A.V. FISTULA NEEDLE SET

K993118 is an FDA 510(k) clearance for BIOTEQUE A.V. FISTULA NEEDLE SET, manufactured by Bioteque Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K993118 · Bioteque Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
88d
Days
Class 2
Risk

K993118 is an FDA 510(k) clearance for the BIOTEQUE A.V. FISTULA NEEDLE SET. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Bioteque Corp. (Flaggstaff, US). The FDA issued a Cleared decision on December 17, 1999 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Bioteque Corp. devices

FDA 510(k) Submission Details - K993118

510(k) Number K993118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1999
Decision Date December 17, 1999
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 131d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIE Device Classification - Class 2, Special Controls

Product Code FIE Needle, Fistula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - FIE Needle, Fistula

All 59
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K993118.
MODIFICATION TO JMS APHERESIS NEEDLE
K000843 · Jms Co., Ltd. · Apr 2000
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
K000845 · Jms Co., Ltd. · Apr 2000
MEDISYSTEMS BUTTONHOLE NEEDLE SETS
K990803 · Medisystems Corp. · Jan 2000
SHELLY PROTECTED AV FISTULA NEEDLE
K992653 · Diasol, Inc. · Oct 1999
JMS A. V. FISTULA NEEDLE SET
K990470 · Jms Co., Ltd. · Aug 1999
JMS APHERESIS NEEDLE
K990510 · Jms Co., Ltd. · Aug 1999