Cleared Traditional

K802444 - PAPILLOTOME PRODUCT (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K802444 · Mill-Rose Laboratory · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 130d · This submission: 16d
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 186
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K802444.
Vanquish Water Vapor Ablation Device
K252388 · Francis Medical, Inc. · Nov 2025
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
K252889 · Olympus Medical Systems Corporation · Nov 2025
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)
K250945 · Olympus Medical Systems Corp. · Oct 2025
Single Use Electrosurgical Knife (KD-612L, KD-612U)
K250351 · Olympus Medical Systems Corporation · Oct 2025
SureTome™ SW Sphincterotome with DomeTip
K251104 · Wilson Cook Medical · Sep 2025
Aqua Medical RF Vapor Ablation System
K251226 · Aqua Medical, Inc. · Aug 2025