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510(k) Data Aggregation
K Number
K203450Device Name
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
Manufacturer
CapNostics, LLC
Date Cleared
2021-05-04
(162 days)
Product Code
EOX
Regulation Number
874.4710Why did this record match?
Applicant Name (Manufacturer) :
CapNostics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The gathering and recovery of cells and cellular material from the mucosa in the esophagus for cytological and histological analyses.
Device Description
The EsophaCap® Swallowable Cellular Retrieval Device is a non-sterile, non-endoscopic, singleuse Esophageal cell sampling device. The EsophaCap® is composed of an open-cell polyether polyurethane foam sphere attached to a polyester tether cap. The open-cell foam sphere ranging in diameter sizes from 20 mm to 35mm is compressed and encapsulated within a vegetable (hypromellose (HPMC)) capsule. When swallowed the EsophaCap® capsule dissolves releasing the foam sphere. The foam sphere expands to form a cytology and cellular retrieval device that allows a circumferential "bottle brush" collection using the expanded "open cell" foam sphere. The radiopaque polyester tether/stylus is used to slowly withdraw the foam sphere through the esophagus and then to subsequently retrieve the foam sphere with the cellular sample.
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