FDA product code NCR: Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
NCR is the FDA product code for apparatus, cutting, radiofrequency, electrosurgical, battery-powered. It is a Class II device, regulated under 21 CFR 886.4100 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under NCR. The average 510(k) review took 166 days (median 171). FDA has posted 1 recall for NCR devices.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.4100 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NCR clearance
Top NCR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medisurg , Ltd. | 3 | 2005-12-09 |
Most recent NCR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050933 | Medisurg , Ltd. | FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 | 2005-12-09 | 239 |
| K041019 | Medisurg , Ltd. | THE FUGO BLADE FOR GLAUCOMA | 2004-10-08 | 171 |
| K001498 | Medisurg , Ltd. | THE FUGO BLADE | 2000-08-10 | 87 |
Recalls for NCR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-04-28.
Frequently asked questions
What is FDA product code NCR?
NCR is the FDA product code for apparatus, cutting, radiofrequency, electrosurgical, battery-powered. It is a Class II device, regulated under 21 CFR 886.4100 and reviewed by the Ophthalmic panel.
What device class is NCR?
Class II, regulation 21 CFR 886.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code NCR?
Across 3 cleared submissions the average was 166 days from receipt to decision (median 171).
Which companies have the most NCR clearances?
Medisurg , Ltd. (3).
Have NCR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-04-28.
Next steps
- Run an FDA pathway report with predicate devices for product code NCR
- Run a recall and safety report across every NCR manufacturer
- Watch product code NCR 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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