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FDA 510(k), K043288, MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
FDA 510(k), K043288, MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
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510(K) Number: K043288
Device Name: MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
Manufacturer: USHA KREADEN
Device Classification Name: System, Surgical, Computer Controlled Instrument
Regulation Number: NAY
Classification Product Code: 11/29/2004
Date Received: 03/03/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
Manufacturer: USHA KREADEN
Device Classification Name: System, Surgical, Computer Controlled Instrument
Regulation Number: NAY
Classification Product Code: 11/29/2004
Date Received: 03/03/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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