510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822516Substantially Equivalent

Vivonex Mass Gastrastomy Tube

Norwich Eaton Pharmaceuticals, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822516 is the FDA 510(k) clearance record for VIVONEX MASS GASTRASTOMY TUBE, a class I device, cleared for Norwich Eaton Pharmaceuticals, Inc. on under FDA product code KHT (Fraction V, Antigen, Antiserum, Control). FDA records list 10 510(k) clearances for Norwich Eaton Pharmaceuticals, Inc., from to . As of , FDA records show no recalls naming K822516.

Clearance record

Decision date
Received
(18 days to decision)
Product code
KHT Fraction V, Antigen, Antiserum, Control
Regulation
21 CFR 866.5370
Device class
Class I
Review panel
Immunology
Applicant
Norwich Eaton Pharmaceuticals, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KHT

Trailing 12 months

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

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