# OCL: Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 54
- 510(k) review time 2021–2025: median 94 days (middle half 29–214)
- Recalls: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 2
- 2014: 1
- 2017: 1
- 2018: 2
- 2019: 6
- 2020: 1
- 2021: 2
- 2022: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880 (2002), cited by 12
- K970496: Heartport Maze System: Cryoprobe Set (1997), cited by 6
- K011040: Cryocare Cardiac Surgical System (2001), cited by 5
- K080509: Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device, Gemini-Ssurgical Ablation Device (2008), cited by 5
- K053436: Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console (2006), cited by 4
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), cited by 4
- K974320: Cryogen Cardiac Cryosurgical System (1998), cited by 3
- K050459: Atricure Isolator Transpolar Pen (2005), cited by 3
- K043579: Atricure Bipolar System (2007), cited by 3
- K021010: Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE (2002), cited by 3

Source page: https://510kreport.com/product-code/OCL
Data by year (CSV): https://510kreport.com/product-code/OCL.csv