FDA applicant

Surgin Surgical Instrumentation, Inc.

Tustin, CA23 decisions1993–20090 recalls

FDA records 23 decisions for Surgin Surgical Instrumentation, Inc. (Tustin, CA) from 1993 to 2009: 23 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and GCJ (Laparoscope, General & Plastic Surgery). No recall is linked to its devices.

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

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Surgin Surgical Instrumentation, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Surgin Surgical Instrumentation, Inc.’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 “Surgin”

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

Surgin, Inc. 1

Surgin Surgical Instrumentation, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Surgin”