ENDOSCOPIC RETRIEVAL BASKET— 510(k) K922114

Substantially Equivalent

Intramed Laboratories, Inc.

FDA 510(k) clearance K922114 for ENDOSCOPIC RETRIEVAL BASKET, Substantially Equivalent on 1992-08-03. Applicant: Intramed Laboratories, Inc..

Clearance details

Applicant: Intramed Laboratories, Inc.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1992-05-05
Decision date: 1992-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

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.