# K160493: Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm

- Pathway: 510(k) (Traditional)
- Applicant: Salvin Dental Specialties
- Decided: Sep 8, 2016 after 199 days
- Product code: NPK (Barrier, Synthetic, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- 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 K922627 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012144: Cytoflex, Unicare Biomedical, Inc. (2001) Summary page 4.

## Most influential descendants
- K222549: OpenTex (2023), 0 descendants of its own

## Indications for use
The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

Source page: https://510kreport.com/device/K160493
Methodology: https://510kreport.com/methodology