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FDA 510(k)

LAPAROCOPIC MYOMA SCREW

K-Number: K915388 · 1992-05-18

ApplicantCook Urological, Inc.
Decision Date1992-05-18
Product CodeHHO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPAROCOPIC MYOMA SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1992-05-18 under 510(k) number K915388. The device is classified under product code HHO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROCOPIC MYOMA SCREW?

LAPAROCOPIC MYOMA SCREW is a medical device that received FDA 510(k) clearance on 1992-05-18. The listed applicant is Cook Urological, Inc.. The 510(k) number is K915388.

When did LAPAROCOPIC MYOMA SCREW receive FDA 510(k) clearance?

LAPAROCOPIC MYOMA SCREW received FDA 510(k) clearance on 1992-05-18, under 510(k) number K915388.

Who is the listed applicant for LAPAROCOPIC MYOMA SCREW?

The FDA 510(k) record lists Cook Urological, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROCOPIC MYOMA SCREW?

The FDA product code for LAPAROCOPIC MYOMA SCREW is HHO.

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Other records listing Cook Urological, Inc. as applicant

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Related Devices (Code: HHO)

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.

K915412HYSTEROSCOPIC MYOMA SCREWCook Urological, 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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