SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES— 510(k) K031869
Substantially EquivalentSurgical Instruments Service and Savings, Inc.
FDA 510(k) clearance K031869 for SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, Substantially Equivalent on 2003-12-24. Applicant: Surgical Instruments Service and Savings, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Instruments Service and Savings, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sisters, OR, US
Recent devices under product code GEI
view allMore clearances from Surgical Instruments Service and Savings, Inc.
view all- K124033 — MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
- K030179 — MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
- K024011 — SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES
- K012644 — REPROCESSED TROCARS AND CANNULAS
- K012669 — REPROCESSED ELECTROSURGICAL ELECTRODES
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.