VERSABLADE— 510(k) K852706

Name: FDA 510(k) clearance K852706
Creator: U.S. Food and Drug Administration
Published: 1985-11-04

Substantially Equivalent for Some Indications

Alphamedix, Inc.

FDA 510(k) clearance K852706 for VERSABLADE, Substantially Equivalent for Some Indications on 1985-11-04. Applicant: Alphamedix, Inc.. Device class: 1.

Clearance details

Applicant: Alphamedix, Inc.
Product code: Code HNN
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1985-06-26
Decision date: 1985-11-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

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K852633 — VERSABLADE1985-11-04
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K830812 — ALPHAMEDIX I/A HAND-PIECE, 500-0011983-06-08
K830703 — GLOMARK1983-04-28
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Adverse events under product code HNN

product code HNN

Injury: 183
Malfunction: 4,106
Total: 4,289

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.