Cleared Traditional

K955247 - OLYMPUS KD SERIES SPHINCTEROTOME

K955247 is the FDA 510(k) clearance for OLYMPUS KD SERIES SPHINCTEROTOME by Olympus America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K955247 · Olympus America, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 1996
Decision
167d
Days
Class 2
Risk

K955247 is an FDA 510(k) clearance for the OLYMPUS KD SERIES SPHINCTEROTOME. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on April 30, 1996 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K955247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1995
Decision Date April 30, 1996
Days to Decision 167 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
37d slower than avg
Panel avg: 130d · This submission: 167d
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 115
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K955247.
PAPILLOTOME
K962346 · United States Endoscopy Group, Inc. · Aug 1996
REUSABLE ENDOSCOPIC ACCESSORY HANDLE
K961762 · United States Endoscopy Group, Inc. · Jul 1996
INJECTION GOLD PROBE
K961349 · Boston Scientific Corp · May 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
HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP
K945764 · Aaron Medical Industries · Jan 1995