# Pristine Surgical

- Location (FDA's records): Manchester, NH
- FDA decisions: 3 (2019–2022): 3 510(k) clearances
- Product codes: HRX (2), GCJ (1)
- 510(k) review time since 2016: median 62 days, against 61 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 0 (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

## Recent decisions
- K223244: Pristine Arthroscopic Visualization System (Dec 21, 2022)
- K193161: Pristine Scope (Apr 21, 2020)
- K183165: Pristine Scope (Jan 16, 2019)

Source page: https://510kreport.com/company/pristine-surgical