SPHINCTEROTOME— 510(k) K960231

Name: FDA 510(k) clearance K960231
Creator: U.S. Food and Drug Administration
Published: 1996-07-31

Substantially Equivalent

Lighthouse Medical, Inc.

FDA 510(k) clearance K960231 for SPHINCTEROTOME, Substantially Equivalent on 1996-07-31. Applicant: Lighthouse Medical, Inc.. Device class: 2.

Clearance details

Applicant: Lighthouse Medical, Inc.
Product code: Code KNS
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 1996-01-17
Decision date: 1996-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.