510(k) K193563
K193563 is an FDA 510(k) premarket notification submitted by Surgical Instrument Service and Savings Inc.(Dba Medline Ren for the device "Medline ReNewal Reprocessed Harmonic ACE+7 Shears". The FDA issued a decision of Substantially Equivalent on August 19, 2020. The device falls under product code NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments), a Class U device. Surgical Instrument Service and Savings Inc.(Dba Medline Ren has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2020
- Date Received
- December 23, 2019
- 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).