Cleared Traditional

K961846 - NEEDLE CATHETER

K961846 is an FDA 510(k) clearance for NEEDLE CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K961846 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
63d
Days
Class 2
Risk

K961846 is an FDA 510(k) clearance for the NEEDLE CATHETER. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on July 15, 1996 after a review of 63 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K961846

510(k) Number K961846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1996
Decision Date July 15, 1996
Days to Decision 63 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
68d faster than avg
Panel avg: 131d · This submission: 63d
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 69
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K961846.
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
MARTECH ENDOSCOPIC INJECTION NEEDLE
K960519 · Martech Medical Products, Inc. · May 1996
GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES
K955558 · Medi-Globe Corp. · Feb 1996
WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
K954519 · Mill-Rose Laboratory · Dec 1995