X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM— 510(k) K041824
Substantially EquivalentFuture Medical Systems, SA
FDA 510(k) clearance K041824 for X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM, Substantially Equivalent on 2005-01-07. Applicant: Future Medical Systems, SA. Device class: 2.
Clearance details
- Applicant
- Future Medical Systems, SA
- 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
- St. Jeannet, FR
Recent devices under product code HRX
view allMore clearances from Future Medical Systems, SA
view allAdverse 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 →
Recalls naming K041824
K-number listed on FDA's recall record- Z-0656-2016 — FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
- Z-0657-2016 — FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041824.
Data sourced from openFDA. This site is unofficial and independent of the FDA.