510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770945Substantially Equivalent

Pouch, Tyvek-Polymylon

Medical Disposables Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770945 is the FDA 510(k) clearance record for POUCH, TYVEK-POLYMYLON, a class II device, cleared for Medical Disposables Intl., Inc. on under FDA product code FPK (Tubing, Fluid Delivery). FDA records list 6 510(k) clearances for Medical Disposables Intl., Inc., from to . As of , FDA records show no recalls naming K770945.

Clearance record

Decision date
Received
(35 days to decision)
Product code
FPK Tubing, Fluid Delivery
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Medical Disposables Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FPK

Trailing 12 months

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

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