FDA applicant

Iscience Surgical Corporation

Irvine, CA3 decisions2004–20060 recalls

FDA records 3 decisions for Iscience Surgical Corporation (Irvine, CA) from 2004 to 2006: 3 510(k) clearances. Most are in product codes MPA (Endoilluminator) and MRH (Pump, Infusion, Ophthalmic). Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Iscience Surgical”.

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 Surgical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Iscience Surgical Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Iscience Surgical Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Iscience Surgical Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Iscience”

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

Iscience Interventional 1

Iscience Surgical Corporation

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Iscience”