510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933085Substantially Equivalent

Goodman Bandage

Megadyne Medical Products, Inc, Draper UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933085 is the FDA 510(k) clearance record for GOODMAN BANDAGE, a class I device, cleared for Megadyne Medical Products, Inc. on under FDA product code KGY (Bag, Intestine). FDA records list 50 510(k) clearances for Megadyne Medical Products, Inc., from to . As of , FDA records show no recalls naming K933085.

Clearance record

Decision date
Received
(183 days to decision)
Product code
KGY Bag, Intestine
Regulation
21 CFR 878.4100
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Megadyne Medical Products, Inc. 11506 S. State St., Draper UT
510(k) summary
Statement
Third party review
No

Clearances, product code KGY

Trailing 12 months

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

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