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FDA 510(k)

CERVEX-BRUSH

K-Number: K890848 · 1989-05-11

ApplicantUnimar, Inc.
Decision Date1989-05-11
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CERVEX-BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Unimar, Inc.. It received FDA 510(k) clearance on 1989-05-11 under 510(k) number K890848. 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 CERVEX-BRUSH?

CERVEX-BRUSH is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Unimar, Inc.. The 510(k) number is K890848.

When did CERVEX-BRUSH receive FDA 510(k) clearance?

CERVEX-BRUSH received FDA 510(k) clearance on 1989-05-11, under 510(k) number K890848.

Who is the listed applicant for CERVEX-BRUSH?

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

What is the FDA product code for CERVEX-BRUSH?

The FDA product code for CERVEX-BRUSH is HHT.

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Other records listing Unimar, Inc. as applicant

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.

K932432KRONNER REINFORCING STYLETTEK920803HSG TRAYK910317UNI-SEM(TM)K904473KRONNER MANIPUJECTORK895659HUI MINI-FLEXK895403ASPIRETTE ENDOCERVICAL ASPIRATOR

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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.

K182049exCellerator Cervical Collection DeviceExcell Company, LLCK153128Kolplast Cervical Sample Collection KitKolplast CI SAK111681HISTOBRUSHPuritan Medical Products Company, LLCK083012PAPCONEOtto Bock Pur Life Science GmbHK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, Inc.

Official Source

View on FDA Database →

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

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