510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921019Substantially Equivalent

Hargis Rectal Self Retration System

Medin Corp., Wallington NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921019 is the FDA 510(k) clearance record for HARGIS RECTAL SELF RETRATION SYSTEM, a class I device, cleared for Medin Corp. on under FDA product code GAD (Retractor). FDA records list 3 510(k) clearances for Medin Corp. As of , FDA records show no recalls naming K921019.

Clearance record

Decision date
Received
(486 days to decision)
Product code
GAD Retractor
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Medin Corp. 111 Lester St., Wallington NJ
510(k) summary
Statement
Third party review
No

Clearances, product code GAD

Trailing 12 months

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

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