MODIFICATION TO CAVERMAP SURGICAL AID— 510(k) K010213
Substantially EquivalentUromed Corp.
FDA 510(k) clearance K010213 for MODIFICATION TO CAVERMAP SURGICAL AID, Substantially Equivalent on 2001-04-20. Applicant: Uromed Corp.. Device class: 2.
Clearance details
- Applicant
- Uromed Corp.
- Product code
- Code ETN
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norwood, MA, US
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More clearances from Uromed Corp.
view allAdverse events under product code ETN
product code ETN- Death
- 7
- Injury
- 327
- Malfunction
- 2,776
- Total
- 3,110
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.