Cleared Traditional

K001146 - GENYX FLEXIBLE INJECTION NEEEDLE

K001146 is an FDA 510(k) clearance for GENYX FLEXIBLE INJECTION NEEEDLE, manufactured by Geny Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K001146 · Geny Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Jun 2000
Decision
81d
Days
Class 2
Risk

K001146 is an FDA 510(k) clearance for the GENYX FLEXIBLE INJECTION NEEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Geny Medical, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on June 30, 2000 after a review of 81 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 Geny Medical, Inc. devices

FDA 510(k) Submission Details - K001146

510(k) Number K001146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date June 30, 2000
Days to Decision 81 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 131d · This submission: 81d
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 71
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K001146.
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE
K030451 · Carbon Medical Technologies, Inc. · Apr 2003
COOK INJECTION NEEDLE
K022484 · Cook Urological, Inc. · Oct 2002
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
GENYX MEDICAL INJECTION NEEDLE
K990996 · Genyx Medical, Inc. · Jun 1999
INJECTION NEEDLE PROBE/DEVICE-TUNIS
K983765 · Ximed/Prosure/Injectx · Dec 1998
ADVANCED UROSCIENCE INJECTION NEEDLE
K982890 · Advanced Uroscience, Inc. · Oct 1998