LOSEFF BALLOON TYPE SELF-RETENTION WOUND— 510(k) K801349

Substantially Equivalent

Loseff Medical Designers, Ltd.

FDA 510(k) clearance K801349 for LOSEFF BALLOON TYPE SELF-RETENTION WOUND, Substantially Equivalent on 1980-08-07. Applicant: Loseff Medical Designers, Ltd..

Clearance details

Applicant: Loseff Medical Designers, Ltd.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 1980-06-09
Decision date: 1980-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.