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FDA 510(k)

WOM HYSTEROFLATOR OP

K-Number: K922632 · 1994-03-25

ApplicantW.O.M. GmbH
Decision Date1994-03-25
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WOM HYSTEROFLATOR OP is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. GmbH. It received FDA 510(k) clearance on 1994-03-25 under 510(k) number K922632. 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 WOM HYSTEROFLATOR OP?

WOM HYSTEROFLATOR OP is a medical device that received FDA 510(k) clearance on 1994-03-25. The listed applicant is W.O.M. GmbH. The 510(k) number is K922632.

When did WOM HYSTEROFLATOR OP receive FDA 510(k) clearance?

WOM HYSTEROFLATOR OP received FDA 510(k) clearance on 1994-03-25, under 510(k) number K922632.

Who is the listed applicant for WOM HYSTEROFLATOR OP?

The FDA 510(k) record lists W.O.M. GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WOM HYSTEROFLATOR OP?

The FDA product code for WOM HYSTEROFLATOR OP is HIG.

Related Clinical Trials

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Other records listing W.O.M. GmbH 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.

K950035SURGIFLATOR 20K921086WOM LAPAROFLATOR ELECTRONIC

Related Devices (Code: HIG)

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

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

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