FDA product code NCB: Weights, Eyelid, Implantable
NCB is the FDA product code for weights, eyelid, implantable. It is a Class II device, regulated under 21 CFR 886.5700 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under NCB. The average 510(k) review took 186 days (median 186). FDA has posted 2 recalls for NCB devices, 2 initiated in the last five years.
Definition
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
Classification
| Field | Value |
|---|---|
| Device name | Weights, Eyelid, Implantable |
| Device class | Class II |
| Regulation | 21 CFR 886.5700 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NCB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 186 |
Top NCB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fci (France Chirurgie Instrumentation) Sas | 1 | 2021-06-11 |
Most recent NCB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203569 | Fci (France Chirurgie Instrumentation) Sas | Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants | 2021-06-11 | 186 |
Recalls for NCB devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-07-12.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code NCB?
NCB is the FDA product code for weights, eyelid, implantable. It is a Class II device, regulated under 21 CFR 886.5700 and reviewed by the Ophthalmic panel.
What device class is NCB?
Class II, regulation 21 CFR 886.5700. Typical premarket route: 510(k).
How long does a 510(k) take for product code NCB?
Across 1 cleared submissions the average was 186 days from receipt to decision (median 186).
Which companies have the most NCB clearances?
Fci (France Chirurgie Instrumentation) Sas (1).
Have NCB devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2024-07-12.
Next steps
- Run an FDA pathway report with predicate devices for product code NCB
- Run a recall and safety report across every NCB manufacturer
- Watch product code NCB 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.