Cleared Traditional

K845015 - DAVOL PAPILLITOME

K845015 is an FDA 510(k) clearance for DAVOL PAPILLITOME, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K845015 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Jan 1985
Decision
20d
Days
Class 2
Risk

K845015 is an FDA 510(k) clearance for the DAVOL PAPILLITOME. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on January 15, 1985 after a review of 20 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K845015

510(k) Number K845015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1984
Decision Date January 15, 1985
Days to Decision 20 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
111d faster than avg
Panel avg: 131d · This submission: 20d
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 K845015.
PAPILLOTOME
K851652 · Microvasive · Jun 1985
E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE
K851964 · Wilson-Cook Medical, Inc. · Jun 1985
HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM
K851096 · Olympus Corp. · May 1985
INFRARED COAGULATOR
K842810 · Endo Lase, Inc. · Oct 1984
DIATHERMIC SNARES
K820430 · American Endoscopy, Inc. · Apr 1982
PAPILLOTOMES
K820240 · American Endoscopy, Inc. · Mar 1982