DOUBLE PUNCTURE INSTRUMENTS— 510(k) K852901

Substantially Equivalent

L.A.S.E.R., Inc.

FDA 510(k) clearance K852901 for DOUBLE PUNCTURE INSTRUMENTS, Substantially Equivalent on 1985-10-16. Applicant: L.A.S.E.R., Inc..

Clearance details

Applicant: L.A.S.E.R., Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1985-07-09
Decision date: 1985-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tomball, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.