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FDA 510(k)

exCellerator Cervical Collection Device

K-Number: K182049 · 2019-04-25

ApplicantExcell Company, LLC
Decision Date2019-04-25
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

exCellerator Cervical Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Excell Company, LLC. It received FDA 510(k) clearance on 2019-04-25 under 510(k) number K182049. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the exCellerator Cervical Collection Device?

exCellerator Cervical Collection Device is a medical device that received FDA 510(k) clearance on 2019-04-25. The listed applicant is Excell Company, LLC. The 510(k) number is K182049.

When did exCellerator Cervical Collection Device receive FDA 510(k) clearance?

exCellerator Cervical Collection Device received FDA 510(k) clearance on 2019-04-25, under 510(k) number K182049.

Who is the listed applicant for exCellerator Cervical Collection Device?

The FDA 510(k) record lists Excell Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for exCellerator Cervical Collection Device?

The FDA product code for exCellerator Cervical Collection Device is HHT.

Related Devices (Code: HHT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153128Kolplast Cervical Sample Collection KitKolplast CI SA

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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