510(k) K030598
K030598 is an FDA 510(k) premarket notification submitted by Medisiss for the device "MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on January 23, 2004. The device falls under product code NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments), a Class U device. Medisiss has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2004
- Date Received
- February 25, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Single-Use Reprocessed Ultrasonic Surgical Instruments
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code LFL). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).