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FDA 510(k)

HYSTEROFLATOR 2001

K-Number: K895907 · 1989-12-14

ApplicantCabot Medical Corp.
Decision Date1989-12-14
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYSTEROFLATOR 2001 is the device name listed in this FDA 510(k) record. The listed applicant is Cabot Medical Corp.. It received FDA 510(k) clearance on 1989-12-14 under 510(k) number K895907. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYSTEROFLATOR 2001?

HYSTEROFLATOR 2001 is a medical device that received FDA 510(k) clearance on 1989-12-14. The listed applicant is Cabot Medical Corp.. The 510(k) number is K895907.

When did HYSTEROFLATOR 2001 receive FDA 510(k) clearance?

HYSTEROFLATOR 2001 received FDA 510(k) clearance on 1989-12-14, under 510(k) number K895907.

Who is the listed applicant for HYSTEROFLATOR 2001?

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

What is the FDA product code for HYSTEROFLATOR 2001?

The FDA product code for HYSTEROFLATOR 2001 is HIG.

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Other records listing Cabot Medical Corp. as applicant

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Related Devices (Code: HIG)

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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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