← FDA Medical Device Classifications
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
OCL · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4400
Classification
- FDA Product Code
OCL- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4400
- Review panel
- CV
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Market data
- Cleared 510(k) submissions
- 54
- Registered establishments
- 31
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown