510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911586Substantially Equivalent

General Hospital Tubing Clamp (Non-Electric)

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

K911586 is the FDA 510(k) clearance record for GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC), a class II device, cleared for Megadyne Medical Products, Inc. on under FDA product code BYY (Tube, Aspirating, Flexible, Connecting). FDA records list 50 510(k) clearances for Megadyne Medical Products, Inc., from to . As of , FDA records show no recalls naming K911586.

Clearance record

Decision date
Received
(84 days to decision)
Product code
BYY Tube, Aspirating, Flexible, Connecting
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Megadyne Medical Products, Inc. 6202 Stratler St., Murray UT
Third party review
No

Clearances, product code BYY

Trailing 12 months

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

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