510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983448Substantially Equivalent

Ml Universal Tubing

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

K983448 is the FDA 510(k) clearance record for ML UNIVERSAL TUBING, a class II device, cleared for Med-Logics, Inc. on under FDA product code MSR (Tubing, Replacement, Phacofragmentation Unit). FDA records list 12 510(k) clearances for Med-Logics, Inc., from to . As of , FDA records show no recalls naming K983448.

Clearance record

Decision date
Received
(79 days to decision)
Product code
MSR Tubing, Replacement, Phacofragmentation Unit
Regulation
21 CFR 886.4150
Device class
Class II
Review panel
Ophthalmic
Applicant
Med-Logics, Inc. 30251 Golden Lantern, Laguna Niguel CA
510(k) summary
Statement
Third party review
No

Clearances, product code MSR

Trailing 12 months

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

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