MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM— 510(k) K011612

Name: FDA 510(k) clearance K011612
Creator: U.S. Food and Drug Administration
Published: 2001-06-22

Substantially Equivalent

Hydrocision, Inc.

FDA 510(k) clearance K011612 for MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM, Substantially Equivalent on 2001-06-22. Applicant: Hydrocision, Inc.. Device class: 2.

Clearance details

Applicant: Hydrocision, Inc.
Product code: Code FQH
Device class: Class 2
Regulation: 21 CFR 880.5475
Advisory panel: General Hospital
Date received: 2001-05-25
Decision date: 2001-06-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Hopkonton, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.