INSUFFLATION NEEDLE, MODEL R65-933— 510(k) K000027
Substantially EquivalentA & A Medical, Inc.
FDA 510(k) clearance K000027 for INSUFFLATION NEEDLE, MODEL R65-933, Substantially Equivalent on 2000-04-03. Applicant: A & A Medical, Inc..
Clearance details
- Applicant
- A & A Medical, Inc.
- Product code
- Code HIF
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Adverse events under product code HIF
product code HIF- Death
- 19
- Injury
- 578
- Malfunction
- 5,639
- Total
- 6,236
Source: openFDA MAUDE database, through . 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.