510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850758Substantially Equivalent

Amniglove & Amnicot

Go Medical Industries Pty., Ltd., Western Australia, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850758 is the FDA 510(k) clearance record for AMNIGLOVE & AMNICOT, a class I device, cleared for Go Medical Industries Pty. , Ltd. on under FDA product code HGE (Amniotome). FDA records list 11 510(k) clearances for Go Medical Industries Pty. , Ltd., from to . As of , FDA records show no recalls naming K850758.

Clearance record

Decision date
Received
(49 days to decision)
Product code
HGE Amniotome
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Go Medical Industries Pty. , Ltd. 20, Denis St., Western Australia, AU
Third party review
No

Clearances, product code HGE

Trailing 12 months

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

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