HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948— 510(k) K013491
Substantially EquivalentA & A Medical, Inc.
FDA 510(k) clearance K013491 for HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948, Substantially Equivalent on 2001-11-19. Applicant: A & A Medical, Inc..
Clearance details
- Applicant
- A & A Medical, Inc.
- Product code
- Code LKF
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Adverse events under product code LKF
product code LKF- Malfunction
- 643
- Other
- 2
- Total
- 645
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.