Cleared Traditional

K983765 - INJECTION NEEDLE PROBE/DEVICE-TUNIS

K983765 is an FDA 510(k) clearance for INJECTION NEEDLE PROBE/DEVICE-TUNIS, manufactured by Ximed/Prosure/Injectx. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K983765 · Ximed/Prosure/Injectx · Gastroenterology & Urology device
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Dec 1998
Decision
46d
Days
Class 2
Risk

K983765 is an FDA 510(k) clearance for the INJECTION NEEDLE PROBE/DEVICE-TUNIS. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Ximed/Prosure/Injectx (San Jose, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 46 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 Ximed/Prosure/Injectx devices

FDA 510(k) Submission Details - K983765

510(k) Number K983765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1998
Decision Date December 11, 1998
Days to Decision 46 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 131d · This submission: 46d
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 73
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K983765.
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
ADVANCED UROSCIENCE INJECTION NEEDLE
K982890 · Advanced Uroscience, Inc. · Oct 1998
NEEDLE CATHETER
K961846 · Boston Scientific Corp · Jul 1996
MARTECH ENDOSCOPIC INJECTION NEEDLE
K960519 · Martech Medical Products, Inc. · May 1996