Cleared Traditional

K961846 - NEEDLE CATHETER

K961846 is the FDA 510(k) clearance for NEEDLE CATHETER by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (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

Submission Details

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
67d faster than avg
Panel avg: 130d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 48
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K961846.
TEGRESS IMPLANT NEEDLE
K050688 · C.R. Bard, Inc. · Apr 2005
ENTERYX INJECTION CATHETER
K042882 · Boston Scientific Corp · Nov 2004
COOK INJECTION NEEDLE
K022484 · Cook Urological, Inc. · Oct 2002
WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
K954519 · Mill-Rose Laboratory · Dec 1995
INJECTION NEEDLE
K953338 · Boston Scientific Corp · Aug 1995
KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS
K950976 · KARL STORZ Endoscopy-America, Inc. · Mar 1995