ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP— 510(k) K010007
Substantially EquivalentTaut, Inc.
FDA 510(k) clearance K010007 for ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP, Substantially Equivalent on 2001-02-22. Applicant: Taut, Inc.. Device class: 2.
Clearance details
- Applicant
- Taut, 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
- Geneva, IL, US
Recent devices under product code GCJ
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- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- 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 Taut, 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 →
Recalls naming K010007
K-number listed on FDA's recall record- Z-1279-2014 — 5/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
- Z-1284-2014 — 5/10/12 mm Weck¿ Vista" Universal Cannula, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
- Z-1326-2014 — 5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010007.
Data sourced from openFDA. This site is unofficial and independent of the FDA.