510(k) Report

FDA applicant

Iscience Interventional

Menlo Park, CA1 decision2008–20082 recalls

FDA records 1 decision for Iscience Interventional (Menlo Park, CA) in 2008: 1 510(k) clearance. All are in product code MPA (Endoilluminator). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Iscience Interventional’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2018

2014: 12018: 1
2008high 1 (2014) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Iscience Interventional by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MPAEndoilluminator1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K080067Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 20083cite it

What has FDA decided for it lately?

  • K080067Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 20082 recalls

The one decision as Iscience Interventional →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K080067ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF…Jan 11, 2018Class II
  • K080067iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile.…Aug 6, 2014Class II

Other applicant names beginning “Iscience”

FDA records each applicant name separately; these may or may not be the same firm.

Iscience Surgical Corporation 3