OBSTETRICAL VACUUM CUP— 510(k) K911326
Substantially EquivalentGesco Intl., Inc.
FDA 510(k) clearance K911326 for OBSTETRICAL VACUUM CUP, Substantially Equivalent on 1991-08-14. Applicant: Gesco Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Gesco Intl., Inc.
- Product code
- Code HDB
- Device class
- Class 2
- Regulation
- 21 CFR 884.4340
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Recent devices under product code HDB
view allMore clearances from Gesco Intl., Inc.
view allAdverse events under product code HDB
product code HDB- Death
- 7
- Total
- 7
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.