# K070233: Conmed Linvatec Smart Guard Irrigator

- Pathway: 510(k) (Special)
- Applicant: Conmed Linvatec
- Decided: Apr 2, 2007 after 67 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K862807 (1986). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971059: Universal Drive System, Linvatec Corp. (1997) Summary page 1.
- K060198: Micropower Hand Piece : Medium Speed Drill, Saggital Saw, Reciprocating Saw, and Oscillating Saw, Linvatec Corp. (2006) Summary page 1.
- K060260: Micropower Hand Piece High Speed Drill, Linvatec Corp. (2006) Summary page 1.
- K060270: Micropower Hand Piece: Oral Max High Speed Drill, Linvatec Corp. (2006) Summary page 1.

## Indications for use
The Hall®Smart Guard® Irrigator is an accessory to a powered instrument system consisting of drills, saws and associated handpieces to perform the cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive and oral/maxillofacial procedures.

Source page: https://510kreport.com/device/K070233
Methodology: https://510kreport.com/methodology