510(k) Report

FDA applicant

Envision Surgical System, Inc.

Palo Alto, CA3 decisions1994–19940 recalls

FDA records 3 decisions for Envision Surgical System, Inc. (Palo Alto, CA) in 1994: 3 510(k) clearances. All are in product code HRX (Arthroscope). 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Envision Surgical System, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HRXArthroscope3decisions

What has FDA decided for it lately?

  • K942427Envision Arthroscope, Cannula,Trocar, Obturator, and ProbeEnvision Surgical System, Inc. · 1994
  • K943666Envision Arthroscopy Visualization SystemEnvision Surgical System, Inc. · 1994
  • K942081Envision Arthroscopy SystemEnvision Surgical System, Inc. · 1994

All 3 as Envision Surgical System, Inc. →

Other applicant names beginning “Envision”

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

Envision Medical Corp. 5Envision Endoscopy 2Envision, Inc. 2Envision Advanced Medical System, Ltd. 1