# K030598: Medisiss Reprocessed Ultrasonic Surgical Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Medisiss
- Decided: Jan 23, 2004 after 332 days
- Product code: NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments)
- Device class: U
- 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 K801623 (1980). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980099: Ultracision  Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)), Ethicon Endo-Surgery, Inc. (1998) Summary page 5.
- K993054: Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141, Ethicon Endo-Surgery, Inc. (1999) Summary page 5.
- K010898: Ultracision Harmonic Scalpel Blades, Model DH105,DH145,SH105, SH145,HC145, Ethicon Endo-Surgery, Inc. (2001) Summary page 5.
- K971861: Ultrasonic Hand Instruments, United States Surgical, A Division of Tyco Healthc (1997) Summary page 5.
- K972114: Olympus Sonosurg System, The Olympus Optical Co. (1998) Summary page 5.

## Indications for use
The SISS d.b.a. MediSISSTM Reprocessed Ultrasonic Surgical Instruments are intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel instruments. The instruments are used in general, pediatric, thoracic, gynecologic, urologic, and other open and endoscopic surgeries for the transection, dissection, and coagulation of tissue(s).

Source page: https://510kreport.com/device/K030598
Methodology: https://510kreport.com/methodology