SURGICAL OBTURATOR WITH SEAL— 510(k) K911730
Substantially EquivalentApplied Vascular Devices, Inc.
FDA 510(k) clearance K911730 for SURGICAL OBTURATOR WITH SEAL, Substantially Equivalent on 1991-12-23. Applicant: Applied Vascular Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Applied Vascular Devices, Inc.
- 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
- Laguna Hills, CA, US
Recent devices under product code GCJ
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- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- 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 Applied Vascular Devices, Inc.
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.