EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)— 510(k) K203450
Substantially EquivalentCapnostics, LLC
FDA 510(k) clearance K203450 for EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata), Substantially Equivalent on 2021-05-04. Applicant: Capnostics, LLC. Device class: 2.
Clearance details
- Applicant
- Capnostics, 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
- Concord, NC, US
Recent devices under product code EOX
view allRecalls naming K203450
K-number listed on FDA's recall record- Z-1899-2024 — Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: No
- Z-1900-2024 — Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: N/A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203450.
Data sourced from openFDA. This site is unofficial and independent of the FDA.