510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080067Substantially Equivalent

Iscience Interventional Ophthalmic Microcatheter

Iscience Interventional, Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080067 is the FDA 510(k) clearance record for ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER, a class II device, cleared for Iscience Interventional on under FDA product code MPA (Endoilluminator). FDA records list one 510(k) clearance for Iscience Interventional. As of , FDA records show 2 recalls naming K080067.

Clearance record

Decision date
Received
(190 days to decision)
Product code
MPA Endoilluminator
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Iscience Interventional 4055 Campbell Ave., Menlo Park CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MPA

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