Cleared Traditional

K802444 - PAPILLOTOME PRODUCT

K802444 is an FDA 510(k) clearance for PAPILLOTOME PRODUCT, manufactured by Mill-Rose Laboratory. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K802444 · Mill-Rose Laboratory · Gastroenterology & Urology device
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Oct 1980
Decision
16d
Days
Class 2
Risk

K802444 is an FDA 510(k) clearance for the PAPILLOTOME PRODUCT. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Mill-Rose Laboratory (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 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 876.4300 - 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 Mill-Rose Laboratory devices

FDA 510(k) Submission Details - K802444

510(k) Number K802444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1980
Decision Date October 23, 1980
Days to Decision 16 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
115d faster than avg
Panel avg: 131d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

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 151
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K802444.
DIATHERMIC SNARES
K820430 · American Endoscopy, Inc. · Apr 1982
PAPILLOTOMES
K820240 · American Endoscopy, Inc. · Mar 1982
POLYPECTOMY SNARE
K810336 · Medi-Tech, Inc. · Mar 1981
CONCEPT SUCTION COAGULATOR
K800321 · Concept, Inc. · Feb 1980
PAPILLOTOMY KNIVES
K780774 · Olympus Corp. · Jul 1978
CORD, ELECTROSURGICAL-STERILE & DISPOS.
K770280 · V. Mueller O.V. Baxter Healthcare Corp. · Apr 1977