# K170030: Novatech Talcair

- Pathway: 510(k) (Traditional)
- Applicant: Novatech SA
- Decided: Mar 13, 2017 after 68 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952443 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151832: Novatech Talcair, Novatech SA (2016) Summary page 4.

## Indications for use
The device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.

Source page: https://510kreport.com/device/K170030
Methodology: https://510kreport.com/methodology