Cleared Traditional

BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME

K990376 · Ballard Medical Products · Gastroenterology & Urology
May 1999
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K990376 is an FDA 510(k) clearance for the BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Ballard Medical Products (Draper, US). The FDA issued a Cleared decision on May 3, 1999, 84 days after receiving the submission on February 8, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K990376 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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