Cleared Traditional

K013384 - SHARGHP A.V. FISTULA NEEDLE SET

K013384 is an FDA 510(k) clearance for SHARGHP A.V. FISTULA NEEDLE SET, manufactured by Shargh Pharmaceutical Co., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K013384 · Shargh Pharmaceutical Co., Inc. · Gastroenterology & Urology device
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Jan 2002
Decision
87d
Days
Class 2
Risk

K013384 is an FDA 510(k) clearance for the SHARGHP A.V. FISTULA NEEDLE SET. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Shargh Pharmaceutical Co., Inc. (Los Angeles, US). The FDA issued a Cleared decision on January 7, 2002 after a review of 87 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 Shargh Pharmaceutical Co., Inc. devices

FDA 510(k) Submission Details - K013384

510(k) Number K013384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2001
Decision Date January 07, 2002
Days to Decision 87 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
44d faster than avg
Panel avg: 131d · This submission: 87d
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 68
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K013384.
NIPRO SAFETOUCH II GAMMA
K063721 · Nipro Medical Corp. · Jan 2007
SUPERCATH V
K052267 · Togo Medikit Co., Ltd. · Oct 2006
JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
K051814 · Jms North America Corp. · Aug 2005
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
K002352 · Jms Co., Ltd. · Sep 2001
RENAX A.V. FISTULA NEEDLE SETS
K003123 · Sunder Biomedical Tech. Co., Ltd. · May 2001
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813 · Nipro Medical Corp. · Nov 2000