510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980696Substantially Equivalent

Foam Tip Injector

Staar Surgical AG, Monrovia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980696 is the FDA 510(k) clearance record for FOAM TIP INJECTOR, a class I device, cleared for Staar Surgical Co. on under FDA product code MSS (Folders And Injectors, Intraocular Lens (Iol)). FDA records list 24 510(k) clearances for Staar Surgical Co., from to . As of , FDA records show one recall naming K980696.

Clearance record

Decision date
Received
(200 days to decision)
Product code
MSS Folders And Injectors, Intraocular Lens (Iol)
Regulation
21 CFR 886.4300
Device class
Class I
Review panel
Ophthalmic
Applicant
Staar Surgical Co. 1911 Walker Ave., Monrovia CA
510(k) summary
Summary
Third party review
No

Clearances, product code MSS

Trailing 12 months
1 clearance under product code MSS in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MSS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260