510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K952652Substantially Equivalent

Medscand Endorette Endometrial Sampler

Medscand (USA), Inc., Hollywood FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952652 is the FDA 510(k) clearance record for MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER, a class II device, cleared for Medscand (Usa), Inc. on under FDA product code HHK (Curette, Suction, Endometrial (And Accessories)). FDA records list one 510(k) clearance for Medscand (Usa), Inc. As of , FDA records show no recalls naming K952652.

Clearance record

Decision date
Received
(98 days to decision)
Product code
HHK Curette, Suction, Endometrial (And Accessories)
Regulation
21 CFR 884.1175
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medscand (Usa), Inc. P.O. Box 7733, Hollywood FL
510(k) summary
Summary
Third party review
No

Clearances, product code HHK

Trailing 12 months

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

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