TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS— 510(k) K855176

Name: FDA 510(k) clearance K855176
Creator: U.S. Food and Drug Administration
Published: 1986-05-13

Substantially Equivalent

Urologic Surgical Devices Corp.

FDA 510(k) clearance K855176 for TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS, Substantially Equivalent on 1986-05-13. Applicant: Urologic Surgical Devices Corp.. Device class: 2.

Clearance details

Applicant: Urologic Surgical Devices Corp.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1985-12-26
Decision date: 1986-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FBK

product code FBK

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.