Cleared Traditional

K961349 - INJECTION GOLD PROBE

K961349 is the FDA 510(k) clearance for INJECTION GOLD PROBE by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K961349 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
37d
Days
Class 2
Risk

K961349 is an FDA 510(k) clearance for the INJECTION GOLD PROBE. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on May 15, 1996 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 K961349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1996
Decision Date May 15, 1996
Days to Decision 37 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
93d faster than avg
Panel avg: 130d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 114
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K961349.
KARL STORZ REMORGIDA FORCEPS
K962083 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
PAPILLOTOME
K962346 · United States Endoscopy Group, Inc. · Aug 1996
REUSABLE ENDOSCOPIC ACCESSORY HANDLE
K961762 · United States Endoscopy Group, Inc. · Jul 1996
OLYMPUS KD SERIES SPHINCTEROTOME
K955247 · Olympus America, Inc. · Apr 1996
CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS
K946109 · Cabot Medical Corp. · Nov 1995
OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE
K950166 · Olympus America, Inc. · Feb 1995