510(k) Report

FDA applicant

Surgical Instrument, Inc.

Placentia, CA3 decisions1988–19940 recalls

FDA records 3 decisions for Surgical Instrument, Inc. (Placentia, CA) from 1988 to 1994: 3 510(k) clearances. Most are in product codes HMX (Cannula, Ophthalmic) and GBX (Catheter, Irrigation). 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 Surgical Instrument, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgical Instrument, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • HMXCannula, Ophthalmic1decision
  • GBXCatheter, Irrigation1decision
  • GCJLaparoscope, General & Plastic Surgery1decision

What has FDA decided for it lately?

  • K930607GripperSurgical Instrument, Inc. · 1994
  • K923667Irrigation/Suction ProbeSurgical Instrument, Inc. · 1993
  • K881487Ophthalmic CannulaSurgical Instrument, Inc. · 1988

All 3 as Surgical Instrument, Inc. →