Cleared Traditional

K992653 - SHELLY PROTECTED AV FISTULA NEEDLE

K992653 is an FDA 510(k) clearance for SHELLY PROTECTED AV FISTULA NEEDLE, manufactured by Diasol, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K992653 · Diasol, Inc. · Gastroenterology & Urology device
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Oct 1999
Decision
82d
Days
Class 2
Risk

K992653 is an FDA 510(k) clearance for the SHELLY PROTECTED AV FISTULA NEEDLE. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Diasol, Inc. (North Hollywood, US). The FDA issued a Cleared decision on October 27, 1999 after a review of 82 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 Diasol, Inc. devices

FDA 510(k) Submission Details - K992653

510(k) Number K992653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1999
Decision Date October 27, 1999
Days to Decision 82 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
48d faster than avg
Panel avg: 130d · This submission: 82d
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 29
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K992653.
NIPRO BIOHOLE NEEDLE
K063368 · Nipro Medical Corp. · Feb 2007
NIPRO SAFETOUCH II GAMMA
K063721 · Nipro Medical Corp. · Jan 2007
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813 · Nipro Medical Corp. · Nov 2000
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
K991623 · Nipro Medical Corp. · Aug 1999
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990
TERUMO AV FISTULA NEEDLE SET
K891062 · Terumo Medical Corp. · Jun 1989