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FDA 510(k)

ROVERS ENDOCERVEX-BRUSH

K-Number: K001119 · 2000-05-19

ApplicantRovers Medical Devices B.V.
Decision Date2000-05-19
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ROVERS ENDOCERVEX-BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Rovers Medical Devices B.V.. It received FDA 510(k) clearance on 2000-05-19 under 510(k) number K001119. 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 ROVERS ENDOCERVEX-BRUSH?

ROVERS ENDOCERVEX-BRUSH is a medical device that received FDA 510(k) clearance on 2000-05-19. The listed applicant is Rovers Medical Devices B.V.. The 510(k) number is K001119.

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

ROVERS ENDOCERVEX-BRUSH received FDA 510(k) clearance on 2000-05-19, under 510(k) number K001119.

Who is the listed applicant for ROVERS ENDOCERVEX-BRUSH?

The FDA 510(k) record lists Rovers Medical Devices B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROVERS ENDOCERVEX-BRUSH?

The FDA product code for ROVERS ENDOCERVEX-BRUSH is HHT.

Related Clinical Trials

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.

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Other records listing Rovers Medical Devices B.V. 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.

K043369CERVEX-BRUSH COMBIK002520ROVERS SPATULA

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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