510(k) K080617
K080617 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on June 27, 2008. The device falls under product code HRX (Arthroscope), a Class II device regulated under 21 CFR 888.1100. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2008
- Date Received
- March 4, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Arthroscope
- Device Class
- Class II
- Regulation Number
- 888.1100
- Review Panel
- OR
- Submission Type
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).