510(k) K031869
K031869 is an FDA 510(k) premarket notification submitted by Surgical Instruments Service and Savings, Inc. for the device "SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on December 24, 2003. The device falls under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories), a Class II device regulated under 21 CFR 878.4400. Surgical Instruments Service and Savings, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 24, 2003
- Date Received
- June 17, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Electrosurgical, Cutting & Coagulation & Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).