INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300— 510(k) K990441

Name: FDA 510(k) clearance K990441
Creator: U.S. Food and Drug Administration
Published: 1999-05-12

Substantially Equivalent

Sandhill Scientific, Inc.

FDA 510(k) clearance K990441 for INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300, Substantially Equivalent on 1999-05-12. 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: 1999-02-11
Decision date: 1999-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
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.