Siss Inc. (D.B.A. Medisiss) Reprocessed Electrosurgical Instruments and Accessories
FDA 510(k) K031869 · Surgical Instruments Service and Savings, Inc.
510(k) numberK031869
Submission
- Device name
- Siss Inc. (D.B.A. Medisiss) Reprocessed Electrosurgical Instruments and Accessories
- Applicant
- Surgical Instruments Service and Savings, Inc.
Sisters, OR, US - Received
- June 17, 2003
- Decision date
- December 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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).
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| K124033 | Medisiss Reprocessed Ultrasonic InstrumentsNLQ · Traditional | 01/07/2014SE |
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| K024011 | Siss Reprocessed Hot Biopsy Forceps, Laparoscopic, Endoscopic and Electrosurgical…NLU · Traditional | 12/19/2002SE |
| K012644 | Reprocessed Trocars and CannulasNLM · Traditional | 07/29/2002SE |
| K012669 | Reprocessed Electrosurgical ElectrodesGEI · Traditional | 06/27/2002SE |
| K012667 | Reprocessed Arthroscopic ShapersHRX · Traditional | 06/03/2002SE |
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Questions and answers
When was Siss Inc. (D.B.A. Medisiss) Reprocessed Electrosurgical Instruments and Accessories cleared by the FDA?
Siss Inc. (D.B.A. Medisiss) Reprocessed Electrosurgical Instruments and Accessories (K031869) received a 510(k) decision of Substantially Equivalent on December 24, 2003, 190 days after the submission was received.
What is the product code of K031869?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.