510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K040912Substantially Equivalent

Hydrogel Canalicular Plug

Partners in Biomaterials, Inc., San Dimas CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040912 is the FDA 510(k) clearance record for HYDROGEL CANALICULAR PLUG, cleared for Partners IN Biomaterials, Inc. on under FDA product code LZU (Plug, Punctum). FDA records list one 510(k) clearance for Partners IN Biomaterials, Inc. As of , FDA records show no recalls naming K040912.

Clearance record

Decision date
Received
(222 days to decision)
Product code
LZU Plug, Punctum
Device class
Unclassified
Review panel
Unknown
Applicant
Partners IN Biomaterials, Inc. 466 W. Arrow Hwy., Unit H, San Dimas CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZU

Trailing 12 months

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

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