510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061050Substantially Equivalent

Gynecare Morcellex Tissue Morcellator, Models Mx0100 and Mx0100r

Ethicon, Inc, Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061050 is the FDA 510(k) clearance record for GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R, a class II device, cleared for ETHICON, Inc. on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show one recall naming K061050.

Clearance record

Decision date
Received
(88 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
ETHICON, Inc. P.O Box 151, Rte. 22 W., Somerville NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HET

Trailing 12 months

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

FDA records show no clearances under product code HET in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HET, 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