510(k) K030919
K030919 is an FDA 510(k) premarket notification submitted by Medisiss for the device "SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on July 3, 2003. The device falls under product code NLR (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed), a Class II device regulated under 21 CFR 876.4300. Medisiss has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2003
- Date Received
- March 24, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type
This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical current. This device is indicated for reuse/reprocessing. 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).