# K031869: Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instruments Service and Savings, Inc.
- Decided: Dec 24, 2003 after 190 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K910831 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984240: Endopath Endoscopic Instruments, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.
- K951589: Manual Surgical Insrument, United States Surgical, A Division of Tyco Healthc (1995) Summary page 1.
- K934784: Endopath Endoscopic Electrosurgical Forceps with Cutting Feature, ETHICON, Inc. (1994) Summary page 1.
- K012625: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, Alliance Medical Corp. (2001) Summary page 1.
- K012598: Reprocessed Laparoscopic Electric Instuments, Sterilmed, Inc. (2001). Our OCR of the scanned summary read K012518, FDA’s number for Trace Scientific Alkaline Phosphatase, Two Part Liquid… (Thermo Dma, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SterilMed, Inc. Reprocessed Laparoscopic Electric Instruments”.
- K012700: Vanguard Reprocessed Endoscopic Instruments, Vanguard Medical Concepts, Inc. (2001)

## Indications for use
The SISS Inc. (d.b.a. MediSISS) Reprocessed electrosurgical instruments have applications in a variety of minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation, transection, resection, mobilization, and dissections of tissue.

Source page: https://510kreport.com/device/K031869
Methodology: https://510kreport.com/methodology