SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)— 510(k) K936038

Substantially Equivalent

Surgical Laser Technologies, Inc.

FDA 510(k) clearance K936038 for SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR), Substantially Equivalent on 1994-05-27. Applicant: Surgical Laser Technologies, Inc..

Clearance details

Applicant: Surgical Laser Technologies, Inc.
Product code: Code FJL
Advisory panel: Gastroenterology, Urology
Date received: 1993-12-20
Decision date: 1994-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oaks, PA, 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.