Laparocopic Myoma Screw

FDA 510(k) K915388 · Cook Urological, Inc.

Substantially Equivalent

510(k) numberK915388

Submission

Device name
Laparocopic Myoma Screw
Applicant
Cook Urological, Inc.
Spencer, IN, US
Received
November 29, 1991
Decision date
May 18, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HHO – Screw, Fibroid, Gynecological
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HHO

510(k)DeviceApplicantDecision
K915412Hysteroscopic Myoma ScrewHHO · Traditional Cook Urological, Inc.05/18/1992SE

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Questions and answers

When was Laparocopic Myoma Screw cleared by the FDA?

Laparocopic Myoma Screw (K915388) received a 510(k) decision of Substantially Equivalent on May 18, 1992, 171 days after the submission was received.

What is the product code of K915388?

The FDA product code is HHO – Screw, Fibroid, Gynecological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.