INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000— 510(k) K984444

Name: FDA 510(k) clearance K984444
Creator: U.S. Food and Drug Administration
Published: 1999-01-11

Substantially Equivalent

Sandhill Scientific, Inc.

FDA 510(k) clearance K984444 for INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000, Substantially Equivalent on 1999-01-11. Applicant: Sandhill Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Sandhill Scientific, Inc.
Product code: Code FFX
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 1998-12-14
Decision date: 1999-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Highlands Ranch, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FFX

product code FFX

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.