DACOMED PENILE PROSTHESIS SIZER— 510(k) K870320

Substantially Equivalent

Dacomed Corp.

FDA 510(k) clearance K870320 for DACOMED PENILE PROSTHESIS SIZER, Substantially Equivalent on 1987-03-17. Applicant: Dacomed Corp..

Clearance details

Applicant: Dacomed Corp.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1987-01-28
Decision date: 1987-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.