Cleared Traditional

INFLATOR/DEFLATOR PISTON SYRINGE

K860589 · Microvasive · Gastroenterology & Urology
Apr 1986
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K860589 is an FDA 510(k) clearance for the INFLATOR/DEFLATOR PISTON SYRINGE, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Microvasive (Milford, US). The FDA issued a Cleared decision on April 7, 1986, 47 days after receiving the submission on February 19, 1986. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K860589 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1986
Decision Date April 07, 1986
Days to Decision 47 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KNT — Tubes, Gastrointestinal (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980

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