Cleared Traditional

K895842 - BITOME(TM) BIPOLAR SPHINCTEROTOME

K895842 is an FDA 510(k) clearance for BITOME(TM) BIPOLAR SPHINCTEROTOME, manufactured by Everest Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K895842

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 131d · This submission: 101d
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 152
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K895842.
DOBBHOFF(R) PAPILLOTOME
K896612 · Biosearch Medical Products, Inc. · Feb 1990
PORGES DIATHERMY SNARE
K896507 · Porges Corp. · Jan 1990
PORGES SPHINCTEROTOMES
K896426 · Porges Corp. · Jan 1990
WILTEK PAPILLOTOME
K894861 · Wiltek Medical, Inc. · Dec 1989
MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM
K892895 · Everest Medical Corp. · Sep 1989
MICROVASIVE GOLD PROBE
K885005 · Boston Scientific Corp · Feb 1989