FDA product code CCW: Laryngoscope, Rigid
CCW is the FDA product code for laryngoscope, rigid. It is a Class I device, regulated under 21 CFR 868.5540 and reviewed by the Anesthesiology panel. FDA has cleared 64 510(k) submissions under CCW, from 52 different applicants. The average 510(k) review took 133 days (median 86). FDA has posted 53 recalls for CCW devices, 17 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Laryngoscope, Rigid |
| Device class | Class I |
| Regulation | 21 CFR 868.5540 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for CCW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 199 |
| 2019 | 1 | 46 |
Compare with all 510(k) review times · Search every CCW clearance
Top CCW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Augustine Medical, Inc. | 5 | 1995-12-29 |
| Eastmed Enterprises, Inc. | 5 | 1993-01-26 |
| Minrad, Inc. | 3 | 2006-08-31 |
| Wilson Greatbatch Technologies, Inc. | 2 | 1998-04-30 |
| Michael S. Upsher | 2 | 1983-10-28 |
47 more applicants have CCW clearances. See the full list in Caduvo.
Most recent CCW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191602 | Venner Medical (Singapore) Pte, Ltd. | APA Oxy Blade | 2019-08-02 | 46 |
| K163412 | Girgis Scope, LLC | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) | 2017-06-22 | 199 |
| K140951 | Yeescope Pty. , Ltd. | YEESCOPE LARYNGOSCOPES | 2014-11-10 | 210 |
| K121378 | Prodol Meditec , Ltd. | AIRTRAQ SP AIRTRAQ AVANT | 2012-06-21 | 44 |
| K063477 | Novamed, LLC | NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET | 2007-02-09 | 85 |
Recalls for CCW devices
53 product recalls in 36 recall events; 17 initiated in the last five years and 19 still open. Most recent: 2025-07-11.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2019 | 4 |
| 2020 | 11 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 5 |
| 2025 | 7 |
Frequently asked questions
What is FDA product code CCW?
CCW is the FDA product code for laryngoscope, rigid. It is a Class I device, regulated under 21 CFR 868.5540 and reviewed by the Anesthesiology panel.
What device class is CCW?
Class I, regulation 21 CFR 868.5540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CCW?
Across 64 cleared submissions the average was 133 days from receipt to decision (median 86).
Which companies have the most CCW clearances?
Augustine Medical, Inc. (5); Eastmed Enterprises, Inc. (5); Minrad, Inc. (3); Wilson Greatbatch Technologies, Inc. (2); Michael S. Upsher (2).
Have CCW devices been recalled?
Yes: 53 product recalls across 36 recall events; the most recent began 2025-07-11.
Next steps
- Run an FDA pathway report with predicate devices for product code CCW
- Run a recall and safety report across every CCW manufacturer
- Watch product code CCW 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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