FDA product code NCE: Injector, Capsular Tension Ring
NCE is the FDA product code for injector, capsular tension ring. It is a Class I device, regulated under 21 CFR 886.4300 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under NCE, from 3 different applicants. The average 510(k) review took 114 days (median 106).
Classification
| Field | Value |
|---|---|
| Device name | Injector, Capsular Tension Ring |
| Device class | Class I |
| Regulation | 21 CFR 886.4300 |
| 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 NCE clearance
Top NCE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Duckworth & Kent, Ltd. | 1 | 2004-12-28 |
| Ophtec USA, Inc. | 1 | 2001-07-09 |
| Geuder GmbH | 1 | 2000-10-04 |
Most recent NCE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042478 | Duckworth & Kent, Ltd. | CAPSULE TENSION RING INSERTER, MODEL 7-810 | 2004-12-28 | 106 |
| K011498 | Ophtec USA, Inc. | EASY CONTROL MICRO INSERTER, MODEL ON385 | 2001-07-09 | 55 |
| K001125 | Geuder GmbH | GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING | 2000-10-04 | 180 |
Recalls for NCE devices
openFDA lists no recalls for product code NCE.
Frequently asked questions
What is FDA product code NCE?
NCE is the FDA product code for injector, capsular tension ring. It is a Class I device, regulated under 21 CFR 886.4300 and reviewed by the Ophthalmic panel.
What device class is NCE?
Class I, regulation 21 CFR 886.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NCE?
Across 3 cleared submissions the average was 114 days from receipt to decision (median 106).
Which companies have the most NCE clearances?
Duckworth & Kent, Ltd. (1); Ophtec USA, Inc. (1); Geuder GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NCE
- Run a recall and safety report across every NCE manufacturer
- Watch product code NCE 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times