510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K994289Substantially Equivalent

Suturegroove

Iop, Inc., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994289 is the FDA 510(k) clearance record for SUTUREGROOVE, a class II device, cleared for Iop, Inc. on under FDA product code MML (Weights, Eyelid, External). FDA's definition for product code MML reads: "Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)". FDA records list 7 510(k) clearances for Iop, Inc., from to . As of , FDA records show no recalls naming K994289.

Clearance record

Decision date
Received
(118 days to decision)
Product code
MML Weights, Eyelid, External
Regulation
21 CFR 886.5700
Device class
Class II
Review panel
Ophthalmic
Applicant
Iop, Inc. 3151 Airway Ave., Bldg. I-1, Costa Mesa CA
510(k) summary
Statement
Third party review
No

Clearances, product code MML

Trailing 12 months

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

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