Cleared Traditional

K895842 - BITOME(TM) BIPOLAR SPHINCTEROTOME

K895842 is the FDA 510(k) clearance for BITOME(TM) BIPOLAR SPHINCTEROTOME by Everest Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K895842 · Everest Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
101d
Days
Class 2
Risk

K895842 is an FDA 510(k) clearance for the BITOME(TM) BIPOLAR SPHINCTEROTOME. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Everest Medical Corp. (Minneapolis, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Everest Medical Corp. devices

Submission Details

510(k) Number K895842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1989
Decision Date January 11, 1990
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
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 116
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K895842.
RESECTOSCOPE LOOPS
K903323 · Olympus Corp. · Oct 1990
ZIMMON PAPILLOTOME
K901443 · Wilson-Cook Medical, Inc. · Jun 1990
DOBBHOFF(R) PAPILLOTOME
K896612 · Biosearch Medical Products, Inc. · Feb 1990
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