BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1— 510(k) K010510

Substantially Equivalent

A & A Medical, Inc.

FDA 510(k) clearance K010510 for BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1, Substantially Equivalent on 2001-05-16. Applicant: A & A Medical, Inc..

Clearance details

Applicant: A & A Medical, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2001-02-21
Decision date: 2001-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, 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.