# K043225: Vanguard Reprocessed Ultrasonic Scalpel

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Mar 22, 2005 after 120 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 K925699 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925699: Harmonic Scalpel Laparosonic Clamp Coagulator Acc., Ultracision, Inc. (1993) Summary page 1.
- K980099: Ultracision  Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)), Ethicon Endo-Surgery, Inc. (1998) Summary page 1.
- 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 1.

## Indications for use
Reprocessed Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.

Source page: https://510kreport.com/device/K043225
Methodology: https://510kreport.com/methodology