DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES— 510(k) K934105
Substantially EquivalentSurgical Innovations Corp.
FDA 510(k) clearance K934105 for DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES, Substantially Equivalent on 1994-03-28. Applicant: Surgical Innovations Corp.. Device class: 2.
Clearance details
- Applicant
- Surgical Innovations 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
- Claremont, NH, US
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More clearances from Surgical Innovations 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.