INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES— 510(k) K090159
Substantially EquivalentIncisive Surgical, Inc.
FDA 510(k) clearance K090159 for INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES, Substantially Equivalent on 2009-02-06. Applicant: Incisive Surgical, Inc..
Clearance details
- Applicant
- Incisive Surgical, Inc.
- Product code
- Code GDW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plymouth, MN, US
Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
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.