Skip to content

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)

by Capnostics, LLC

510(k) K203450

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203450 Date4 May 2021ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1899-2024 FDA Class II initiated 24 Apr 2024
    • Ongoing Z-1900-2024 FDA Class II initiated 24 Apr 2024

    The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EOX
Device Class
Class II
Regulation
21 CFR Part 874.4710
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent