# K212049: Oclet TDS 1000

- Pathway: 510(k) (Traditional)
- Applicant: Tendonova Corporation
- Decided: Mar 8, 2022 after 251 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- 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: 6 generations back to K884413 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153299: Tenex Health TX System, Tenex Health, Inc. (2016) Summary page 4.

## Indications for use
The Ocelot TDS 1000 is indicated for use during surgical procedures when fragmentation or debridement of soft tissue is desired.

Source page: https://510kreport.com/device/K212049
Methodology: https://510kreport.com/methodology