SURGICAL STAPLING INSTRU., AUTO, SUTURE— 510(k) K771177
Substantially EquivalentUnited States Surgical, A Division of Tyco Healthc
FDA 510(k) clearance K771177 for SURGICAL STAPLING INSTRU., AUTO, SUTURE, Substantially Equivalent on 1977-10-18. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 2.
Clearance details
- Applicant
- United States Surgical, A Division of Tyco Healthc
- 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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- K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more
More clearances from United States Surgical, A Division of Tyco Healthc
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.