510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010353Substantially Equivalent

Med-Logics Disposable Alk Tubing

Med-logics Inc, Laguna Niguel, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010353 is the FDA 510(k) clearance record for MED-LOGICS DISPOSABLE ALK TUBING, a class I device, cleared for Med-Logics, Inc. on under FDA product code KYG (Device, Irrigation, Ocular Surgery). FDA records list 12 510(k) clearances for Med-Logics, Inc., from to . As of , FDA records show no recalls naming K010353.

Clearance record

Decision date
Received
(80 days to decision)
Product code
KYG Device, Irrigation, Ocular Surgery
Regulation
21 CFR 886.4360
Device class
Class I
Review panel
Ophthalmic
Applicant
Med-Logics, Inc. 2788 Lapaz Rd. #G-316, Laguna Niguel, CA
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