510(k) K111794
K111794 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "REPROCESSED HARMONIC SCALPEL". The FDA issued a decision of Substantially Equivalent on January 11, 2012. The device falls under product code NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments), a Class U device. Sterilmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2012
- Date Received
- June 27, 2011
- 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).