FDA product code OCL: Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
OCL is the FDA product code for surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the Cardiovascular panel. FDA has cleared 54 510(k) submissions under OCL, 4 in the last five years, from 14 different applicants. The average 510(k) review took 105 days (median 80); 132 days on average over the last three years. FDA has posted 17 recalls for OCL devices, 1 initiated in the last five years.
Definition
Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Classification
| Field | Value |
|---|---|
| Device name | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | CV — Cardiovascular |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OCL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
| 2018 | 2 | 59 |
| 2019 | 6 | 79 |
| 2020 | 1 | 93 |
| 2021 | 2 | 92 |
| 2022 | 2 | 132 |
| 2024 | 1 | 242 |
| 2025 | 1 | 23 |
Compare with all 510(k) review times · Search every OCL clearance
Top OCL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| AtriCure, Inc. | 20 | 2025-07-24 |
| Medtronic, Inc. | 7 | 2022-12-22 |
| Ncontact Surgical, Inc. | 6 | 2014-10-28 |
| Medtronic | 4 | 2020-06-03 |
| Cryocath Technologies, Inc. | 3 | 2006-08-24 |
9 more applicants have OCL clearances. See the full list in Caduvo.
Most recent OCL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252056 | AtriCure, Inc. | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | 2025-07-24 | 23 |
| K234151 | AtriCure, Inc. | Isolator Synergy EnCapture Ablation System (EMH) | 2024-08-27 | 242 |
| K221358 | AtriCure, Inc. | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) | 2022-12-30 | 233 |
| K223508 | Medtronic, Inc. | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device | 2022-12-22 | 30 |
| K210477 | AtriCure, Inc. | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | 2021-07-26 | 157 |
Recalls for OCL devices
17 product recalls in 10 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2022-04-20.
| Year | Recalls |
|---|---|
| 2019 | 5 |
| 2020 | 4 |
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code OCL?
OCL is the FDA product code for surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the Cardiovascular panel.
What device class is OCL?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCL?
Across 54 cleared submissions the average was 105 days from receipt to decision (median 80).
Which companies have the most OCL clearances?
AtriCure, Inc. (20); Medtronic, Inc. (7); Ncontact Surgical, Inc. (6); Medtronic (4); Cryocath Technologies, Inc. (3).
Have OCL devices been recalled?
Yes: 17 product recalls across 10 recall events; the most recent began 2022-04-20.
Next steps
- Run an FDA pathway report with predicate devices for product code OCL
- Run a recall and safety report across every OCL manufacturer
- Watch product code OCL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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