MANUAL SURGICAL INSTRUMENTS— 510(k) K921925
Substantially Equivalent3M Health Care, Ltd.
FDA 510(k) clearance K921925 for MANUAL SURGICAL INSTRUMENTS, Substantially Equivalent on 1993-05-26. Applicant: 3M Health Care, Ltd.. Device class: 2.
Clearance details
- Applicant
- 3M Health Care, Ltd.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
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- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from 3M Health Care, Ltd.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.