510(k) Report

FDA applicant

Surgical Design Corp.

Washington, DC4 decisions1994–20051 recall

FDA records 4 decisions for Surgical Design Corp. (Washington, DC) from 1994 to 2005: 4 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and FNM (Mattress, Air Flotation, Alternating Pressure). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Surgical Design, Inc.”.

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 Design Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgical Design Corp. since 2007.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Surgical Design Corp.’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?

  • HQCUnit, Phacofragmentation2decisions
  • FNMMattress, Air Flotation, Alternating Pressure1decision
  • HFXClamp, Circumcision1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K991852Ocusystem Art Advantage, Model 995Surgical Design Corp. · 19991cites it

What has FDA decided for it lately?

  • K043533Surgical Design Circumcision ClampSurgical Design, Inc. · 20051 recall
  • K991852Ocusystem Art Advantage, Model 995Surgical Design Corp. · 1999
  • K961243Ocusystem Art AdvantageSurgical Design Corp. · 1996
  • K934817Surgical Design Corporation Model 700 Low Pressure MattressSurgical Design Corp. · 1994

All 3 as Surgical Design Corp. →The one decision as Surgical Design, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K043533Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used…Jan 26, 2011