Cleared Traditional

MICROINFUSOR

K932306 · Sandhill Scientific, Inc. · Gastroenterology & Urology
Apr 1994
Decision
325d
Days
Class 2
Risk

About This 510(k) Submission

K932306 is an FDA 510(k) clearance for the MICROINFUSOR, a System, Gastrointestinal Motility (electrical) (Class II — Special Controls, product code FFX), submitted by Sandhill Scientific, Inc. (Littleton, US). The FDA issued a Cleared decision on April 1, 1994, 325 days after receiving the submission on May 11, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.

Submission Details

510(k) Number K932306 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1993
Decision Date April 01, 1994
Days to Decision 325 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FFX — System, Gastrointestinal Motility (electrical)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1725