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FDA 510(k)

DIGENE CERVICAL BRUSH

K-Number: K971586 · 1997-09-19

ApplicantDigene Corp.
Decision Date1997-09-19
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DIGENE CERVICAL BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Digene Corp.. It received FDA 510(k) clearance on 1997-09-19 under 510(k) number K971586. 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 DIGENE CERVICAL BRUSH?

DIGENE CERVICAL BRUSH is a medical device that received FDA 510(k) clearance on 1997-09-19. The listed applicant is Digene Corp.. The 510(k) number is K971586.

When did DIGENE CERVICAL BRUSH receive FDA 510(k) clearance?

DIGENE CERVICAL BRUSH received FDA 510(k) clearance on 1997-09-19, under 510(k) number K971586.

Who is the listed applicant for DIGENE CERVICAL BRUSH?

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

What is the FDA product code for DIGENE CERVICAL BRUSH?

The FDA product code for DIGENE CERVICAL BRUSH is HHT.

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Other records listing Digene Corp. as applicant

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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.

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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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