510(k) K150524
K150524 is an FDA 510(k) premarket notification submitted by Surgical Instrument Services and Savings, Inc. for the device "Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology". The FDA issued a decision of Substantially Equivalent on December 16, 2015. The device falls under product code NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments), a Class U device. Surgical Instrument Services and Savings, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2015
- Date Received
- March 2, 2015
- 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).