510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K820115Substantially Equivalent

Emmett IUD Thread Retreiver

Proto-Med, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820115 is the FDA 510(k) clearance record for EMMETT IUD THREAD RETREIVER, a class I device, cleared for Proto-Med, Inc. on under FDA product code HHF (Remover, Intrauterine Device, Contraceptive, Hook-Type). FDA records list 4 510(k) clearances for Proto-Med, Inc., from to . As of , FDA records show no recalls naming K820115.

Clearance record

Decision date
Received
(18 days to decision)
Product code
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Proto-Med, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HHF

Trailing 12 months

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

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