510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K862365Substantially Equivalent

Needle for Amniocentesis and Cyst Puncture

Swemed Laboratories, Inc., Sweden, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862365 is the FDA 510(k) clearance record for NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE, a class I device, cleared for Swemed Laboratories, Inc. on under FDA product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)). FDA records list 2 510(k) clearances for Swemed Laboratories, Inc., from to . As of , FDA records show no recalls naming K862365.

Clearance record

Decision date
Received
(13 days to decision)
Product code
HIO Sampler, Amniotic Fluid (Amniocentesis Tray)
Regulation
21 CFR 884.1550
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Swemed Laboratories, Inc. Fullriggaregatan 12 B, Sweden, SE
Third party review
No

Clearances, product code HIO

Trailing 12 months

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

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