# K062642: RF Surgical Systems Inc. Detection System, Model 100A

- Pathway: 510(k) (Traditional)
- Applicant: Rf Surgical Systems, Inc.
- Decided: Nov 2, 2006 after 57 days
- Product code: LWH (Counter, Sponge, Surgical)
- Device class: 1
- Regulation: 21 CFR 880.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K060076 (2006). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060076: Surgicount Safety-Sponge System, Surgicount Medical (2006) Summary page 1.
- (no number) Tyco/Kendall X-ray Detectable Sponges (Various): named in the summary without a submission number
- (no number) Tyco Bag-IT Sponge Counting System: named in the summary without a submission number

## Most influential descendants
- K073180: Smartsponge Plus System (2007), 2 descendants of its own
- K093557: Smartwand-DTX (2009), 1 descendant of its own
- K113021: Trufreeze System, Trufreeze Spray Kit (2012), 0 descendants of its own
- K100551: Orlocate System Model Orl 100 (2010), 0 descendants of its own

## Indications for use
The RF Surgical Systems Inc. Detection System is intended to provide a non-invasive means of locating retained surgical sponges, gauze and other tagged items within a surgical site. It is to be employed as an adjunctive detection method to current surgical sponge and gauze counting systems and methods

Source page: https://510kreport.com/device/K062642
Methodology: https://510kreport.com/methodology