Cytosponge Cell Collection Device— 510(k) K152794
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K152794 for Cytosponge Cell Collection Device, Substantially Equivalent on 2016-04-12. Applicant: Covidien, LLC. Device class: 2.
Clearance details
- Applicant
- Covidien, LLC
- Product code
- Code EOX
- Device class
- Class 2
- Regulation
- 21 CFR 874.4710
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
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Recalls naming K152794
K-number listed on FDA's recall record- Z-2122-2016 — Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.
- Z-2123-2016 — Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152794.
Data sourced from openFDA. This site is unofficial and independent of the FDA.