HENKE SASS WOLF OF AMERICA ARTHROSCOPE— 510(k) K080560
Substantially EquivalentHenke Sass Wolf of America, Inc.
FDA 510(k) clearance K080560 for HENKE SASS WOLF OF AMERICA ARTHROSCOPE, Substantially Equivalent on 2008-03-18. Applicant: Henke Sass Wolf of America, Inc.. Device class: 2.
Clearance details
- Applicant
- Henke Sass Wolf of America, Inc.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mount Dora, FL, US
Recent devices under product code HRX
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- K991563 — CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C
- K983067 — FINE-JECT
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . 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.