Cleared Traditional

K990376 - BALLARD MEDICAL PRODUCTS FACILETOME BOW...

K990376 is an FDA 510(k) clearance for BALLARD MEDICAL PRODUCTS FACILETOME BOW..., manufactured by Ballard Medical Products. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K990376 · Ballard Medical Products · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
84d
Days
Class 2
Risk

K990376 is an FDA 510(k) clearance for the BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Ballard Medical Products (Draper, US). The FDA issued a Cleared decision on May 3, 1999 after a review of 84 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 Ballard Medical Products devices

FDA 510(k) Submission Details - K990376

510(k) Number K990376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1999
Decision Date May 03, 1999
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 130d · This submission: 84d
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 119
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K990376.
RAPID EXCHANGE TAPERTOME
K002802 · Boston Scientific Corp · Oct 2000
COOPERSURGICAL INFRARED COAGULATOR
K990852 · CooperSurgical, Inc. · Jun 1999
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
K990850 · CooperSurgical, Inc. · Jun 1999
COOPERSURGICAL INFRARED COAGULATOR FOR ENT
K990855 · CooperSurgical, Inc. · Mar 1999
WILSON-COOK BIPOLAR PROBE
K990145 · Wilson-Cook Medical, Inc. · Mar 1999
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
K982289 · Olympus America, Inc. · Aug 1998