FDA product code NKC: Tubing/Tubing With Filter, Insufflation, Laparoscopic
NKC is the FDA product code for tubing/tubing with filter, insufflation, laparoscopic. It is a Class I device, regulated under 21 CFR 884.1730 and reviewed by the Obstetrics and Gynecology panel. Devices under NKC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for NKC devices.
Classification
| Field | Value |
|---|---|
| Device name | Tubing/Tubing With Filter, Insufflation, Laparoscopic |
| Device class | Class I |
| Regulation | 21 CFR 884.1730 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for NKC devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-01-09.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code NKC?
NKC is the FDA product code for tubing/tubing with filter, insufflation, laparoscopic. It is a Class I device, regulated under 21 CFR 884.1730 and reviewed by the Obstetrics and Gynecology panel.
What device class is NKC?
Class I, regulation 21 CFR 884.1730. Typical premarket route: 510(k) exempt.
Have NKC devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2019-01-09.
Next steps
- Run an FDA pathway report with predicate devices for product code NKC
- Run a recall and safety report across every NKC manufacturer
- Watch product code NKC 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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