Cleared Traditional

K896612 - DOBBHOFF PAPILLOTOME

K896612 is the FDA 510(k) clearance for DOBBHOFF PAPILLOTOME by Biosearch Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K896612 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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Feb 1990
Decision
83d
Days
Class 2
Risk

K896612 is an FDA 510(k) clearance for the DOBBHOFF(R) PAPILLOTOME. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on February 12, 1990 after a review of 83 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 Biosearch Medical Products, Inc. devices

Submission Details

510(k) Number K896612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date February 12, 1990
Days to Decision 83 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
47d faster than avg
Panel avg: 130d · This submission: 83d
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 K896612.
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MICROVASIVE GOLD PROBE
K885005 · Boston Scientific Corp · Feb 1989
BALL TIP FULGURATING ELECTRODE, 3 FRENCH
K880748 · Cook Urological, Inc. · Aug 1988
MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE
K864413 · Cooper Lasersonics, Inc. · Dec 1986