ADAPT OPEN ACCESS PORT, MODEL 41233— 510(k) K021731
Substantially EquivalentTaut, Inc.
FDA 510(k) clearance K021731 for ADAPT OPEN ACCESS PORT, MODEL 41233, Substantially Equivalent on 2002-08-08. 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
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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 K021731
K-number listed on FDA's recall record- Z-1285-2014 — 5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, 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-1327-2014 — 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. 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 K021731.
Data sourced from openFDA. This site is unofficial and independent of the FDA.