510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915388Substantially Equivalent

Laparocopic Myoma Screw

Cook Incorporated, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915388 is the FDA 510(k) clearance record for LAPAROCOPIC MYOMA SCREW, a class II device, cleared for Cook Urological, Inc. on under FDA product code HHO (Screw, Fibroid, Gynecological). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K915388.

Clearance record

Decision date
Received
(171 days to decision)
Product code
HHO Screw, Fibroid, Gynecological
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
510(k) summary
Statement
Third party review
No

Clearances, product code HHO

Trailing 12 months

FDA records hold no clearances under product code HHO in the trailing twelve months.

FDA records show no clearances under product code HHO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HHO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260