# Surgitools Pty, Ltd.

- Location (FDA's records): Woodvale, AU
- FDA decisions: 1 (2016–2016): 1 510(k) clearance
- Product codes: HEW (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- J.Singh Instruments: 1 (https://510kreport.com/company/j-singh-instruments)

## Recent decisions
- K161065: ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator (Oct 27, 2016)

Source page: https://510kreport.com/company/surgitools