SURGISORB— 510(k) K990432
Substantially Equivalent for Some IndicationsSutures , Ltd.
FDA 510(k) clearance K990432 for SURGISORB, Substantially Equivalent for Some Indications on 1999-05-27. Applicant: Sutures , Ltd.. Device class: 2.
Clearance details
- Applicant
- Sutures , Ltd.
- Product code
- Code GAM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4493
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Ruabon, Wrexham, GB
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More clearances from Sutures , Ltd.
view allAdverse events under product code GAM
product code GAM- Death
- 45
- Injury
- 5,711
- Malfunction
- 30,744
- Other
- 4
- Total
- 36,504
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.