WEXLER ENDOSCOPE ACCESSORIES— 510(k) K110121
Substantially EquivalentMicrosurgical Laboratories,Inc.Dba Wexler Surgical
FDA 510(k) clearance K110121 for WEXLER ENDOSCOPE ACCESSORIES, Substantially Equivalent on 2011-05-10. Applicant: Microsurgical Laboratories,Inc.Dba Wexler Surgical. Device class: 2.
Clearance details
- Applicant
- Microsurgical Laboratories,Inc.Dba Wexler Surgical
- 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
- Bellaire, TX, 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 Microsurgical Laboratories,Inc.Dba Wexler Surgical
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.