TEFLON COATED RESECTOSCOPE SHEATH— 510(k) K761242

Substantially Equivalent

V. Mueller O.V. Baxter Healthcare Corp.

FDA 510(k) clearance K761242 for TEFLON COATED RESECTOSCOPE SHEATH, Substantially Equivalent on 1976-12-16. Applicant: V. Mueller O.V. Baxter Healthcare Corp..

Clearance details

Applicant: V. Mueller O.V. Baxter Healthcare Corp.
Product code: Code FJL
Advisory panel: Gastroenterology, Urology
Date received: 1976-12-13
Decision date: 1976-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FJL

product code FJL

Death: 2
Total: 2

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.