Cleared Traditional

K953338 - INJECTION NEEDLE

K953338 is an FDA 510(k) clearance for INJECTION NEEDLE, 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 16-day FDA review.

K953338 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
16d
Days
Class 2
Risk

K953338 is an FDA 510(k) clearance for the INJECTION NEEDLE. 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 August 2, 1995 after a review of 16 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 - K953338

510(k) Number K953338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date August 02, 1995
Days to Decision 16 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
115d faster than avg
Panel avg: 131d · This submission: 16d
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 K953338.
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
KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS
K950976 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE
K941305 · Wilson-Cook Medical, Inc. · Jun 1994
BARD ENDOSCOPIC INJECTION SYSTEM
K933815 · C.R. Bard, Inc. · Dec 1993