POWERPUMP ARTHROSCOPY SYSTEM— 510(k) K093409

Name: FDA 510(k) clearance K093409
Creator: U.S. Food and Drug Administration
Published: 2010-02-24

Substantially Equivalent

Medical Vision AB

FDA 510(k) clearance K093409 for POWERPUMP ARTHROSCOPY SYSTEM, Substantially Equivalent on 2010-02-24. Applicant: Medical Vision AB. Device class: 2.

Clearance details

Applicant: Medical Vision AB
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2009-11-02
Decision date: 2010-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ne, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

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K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
K253523 — Freedom DS Decompression System2026-04-16
K252546 — VantageTM Lumbar Decompression Kit2026-03-12

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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 →

Recalls naming K093409

K-number listed on FDA's recall record

Z-2705-2016 — Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.Class II·Terminated·Medical Vision Ab·20160510

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093409.

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