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

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..

Clearance details

Applicant: Sandhill Scientific, Inc.
Product code: Code FFX
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

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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.