AUTO SUTURE DISPOS., EEA SURG. STAPLER— 510(k) K802611
Substantially EquivalentU. S. Surgical Corp.
FDA 510(k) clearance K802611 for AUTO SUTURE DISPOS., EEA SURG. STAPLER, Substantially Equivalent on 1980-11-12. Applicant: U. S. Surgical Corp.. Device class: 2.
Clearance details
- Applicant
- U. S. Surgical Corp.
- Product code
- Code GAG
- Device class
- Class 2
- Regulation
- 21 CFR 878.4740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from U. S. Surgical Corp.
view allAdverse events under product code GAG
product code GAG- Death
- 23
- Injury
- 394
- Malfunction
- 2,304
- Other
- 6
- Total
- 2,727
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.