exCellerator Cervical Collection Device— 510(k) K182049

Name: FDA 510(k) clearance K182049
Creator: U.S. Food and Drug Administration
Published: 2019-04-25

Substantially Equivalent

Excell Company, LLC

FDA 510(k) clearance K182049 for exCellerator Cervical Collection Device, Substantially Equivalent on 2019-04-25. Applicant: Excell Company, LLC. Device class: 2.

Clearance details

Applicant: Excell Company, LLC
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2018-07-31
Decision date: 2019-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, US

Download summary PDF View on FDA.gov ↗

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K081522 — BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY2008-12-05

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