510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970161Substantially Equivalent

Hedges Corneal Wetting Pak

Hedges Cwp, Inc., Cherry Hill NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970161 is the FDA 510(k) clearance record for HEDGES CORNEAL WETTING PAK, a class I device, cleared for Hedges Cwp, Inc. on under FDA product code KYG (Device, Irrigation, Ocular Surgery). FDA records list one 510(k) clearance for Hedges Cwp, Inc. As of , FDA records show no recalls naming K970161.

Clearance record

Decision date
Received
(70 days to decision)
Product code
KYG Device, Irrigation, Ocular Surgery
Regulation
21 CFR 886.4360
Device class
Class I
Review panel
Ophthalmic
Applicant
Hedges Cwp, Inc. 105 Spring House Ct., Cherry Hill NJ
510(k) summary
Statement
Third party review
No

Clearances, product code KYG

Trailing 12 months

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

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