Cleared Traditional

K780774 - PAPILLOTOMY KNIVES

K780774 is the FDA 510(k) clearance for PAPILLOTOMY KNIVES by Olympus Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K780774 · Olympus Corp. · Gastroenterology & Urology device
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Jul 1978
Decision
85d
Days
Class 2
Risk

K780774 is an FDA 510(k) clearance for the PAPILLOTOMY KNIVES. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Olympus Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 85 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 Olympus Corp. devices

Submission Details

510(k) Number K780774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1978
Decision Date July 27, 1978
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 130d · This submission: 85d
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 K780774.
POLYPECTOMY SNARE
K810336 · Medi-Tech, Inc. · Mar 1981
PAPILLOTOME PRODUCT
K802444 · Mill-Rose Laboratory · Oct 1980
CONCEPT SUCTION COAGULATOR
K800321 · Concept, Inc. · Feb 1980
CORD, ELECTROSURGICAL-STERILE & DISPOS.
K770280 · V. Mueller O.V. Baxter Healthcare Corp. · Apr 1977
ELECTRODE, CUTTING LOOP
K760178 · V. Mueller O.V. Baxter Healthcare Corp. · Oct 1976