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
K770708Substantially Equivalent

Tygon Pac-Stopcocks

Norton Performance Plastics Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770708 is the FDA 510(k) clearance record for TYGON PAC-STOPCOCKS, a class II device, cleared for Norton Performance Plastics Corp. on under FDA product code FMG (Stopcock, I.V. Set). FDA records list 39 510(k) clearances for Norton Performance Plastics Corp., from to . As of , FDA records show no recalls naming K770708.

Clearance record

Decision date
Received
(51 days to decision)
Product code
FMG Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Norton Performance Plastics Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FMG

Trailing 12 months

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

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