Cleared Traditional

K012232 - INSIGHT, MODEL S980000
(FDA 510(k) Clearance)

K012232 · Sandhill Scientific, Inc. · Gastroenterology & Urology
Jun 2002
Decision
326d
Days
Class 2
Risk

K012232 is an FDA 510(k) clearance for the INSIGHT, MODEL S980000, a System, Gastrointestinal Motility (electrical) (Class II — Special Controls, product code FFX), submitted by Sandhill Scientific, Inc. (Boulder, US). The FDA issued a Cleared decision on June 7, 2002, 326 days after receiving the submission on July 16, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.

Submission Details

510(k) Number K012232 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2001
Decision Date June 07, 2002
Days to Decision 326 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