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FDA 510(k)

RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)

K-Number: K093508 · 2010-03-04

ApplicantWomancare Global
Decision Date2010-03-04
Product CodeHGH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) is the device name listed in this FDA 510(k) record. The listed applicant is Womancare Global. It received FDA 510(k) clearance on 2010-03-04 under 510(k) number K093508. The device is classified under product code HGH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)?

RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) is a medical device that received FDA 510(k) clearance on 2010-03-04. The listed applicant is Womancare Global. The 510(k) number is K093508.

When did RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) receive FDA 510(k) clearance?

RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) received FDA 510(k) clearance on 2010-03-04, under 510(k) number K093508.

Who is the listed applicant for RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)?

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

What is the FDA product code for RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)?

The FDA product code for RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) is HGH.

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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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