Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5540](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5540) → CCW — Laryngoscope, Rigid # CCW · Laryngoscope, Rigid _Anesthesiology · 21 CFR 868.5540 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW ## Overview - **Product Code:** CCW - **Device Name:** Laryngoscope, Rigid - **Regulation:** [21 CFR 868.5540](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5540) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9 ## Recent Cleared Devices (20 of 64) Showing 20 most recent of 64 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K191602](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K191602.md) | APA Oxy Blade | Venner Medical (Singapore) Pte, Ltd. | Aug 2, 2019 | SESE | | [K163412](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K163412.md) | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) | Girgis Scope, LLC | Jun 22, 2017 | SESE | | [K140951](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K140951.md) | YEESCOPE LARYNGOSCOPES | Yeescope Pty. , Ltd. | Nov 10, 2014 | SESE | | [K121378](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K121378.md) | AIRTRAQ SP AIRTRAQ AVANT | Prodol Meditec , Ltd. | Jun 21, 2012 | SESE | | [K063477](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K063477.md) | NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET | Novamed, LLC | Feb 9, 2007 | SESE | | [K062523](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K062523.md) | TRU-MR LARYNGOSCOPE SET | Truphatek International, Ltd. | Nov 17, 2006 | SESE | | [K062231](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K062231.md) | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 | Minrad, Inc. | Aug 31, 2006 | SESE | | [K062230](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K062230.md) | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 | Minrad, Inc. | Aug 31, 2006 | SESE | | [K041852](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K041852.md) | MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 | Minrad, Inc. | Nov 15, 2004 | SESE | | [K984101](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K984101.md) | FLEXIBLADE | Arco Medic , Ltd. | Sep 3, 1999 | SESE | | [K971377](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K971377.md) | GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE | Wilson Greatbatch Technologies, Inc. | Apr 30, 1998 | SESE | | [K970619](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K970619.md) | GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE | Wilson Greatbatch Technologies, Inc. | Nov 19, 1997 | SESE | | [K945590](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K945590.md) | SCOPETEX(TM) | Smith Helms Mulliss & Moore, L.L.P. | May 20, 1997 | SESE | | [K961832](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K961832.md) | BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER | Blue Ridge Medical, Inc. | Sep 6, 1996 | SESE | | [K945301](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K945301.md) | LARYNGOSCOPE COVER | Sotiria Mourkidou, M.D. | May 31, 1996 | SESE | | [K954787](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K954787.md) | ILLUMINATOR | Hospitak, Inc. | Jan 31, 1996 | SESE | | [K954446](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K954446.md) | AUGUSTINE INTUBATION GUIDE | Augustine Medical, Inc. | Dec 29, 1995 | SESE | | [K954438](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K954438.md) | SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE | Rms Div. | Dec 29, 1995 | SESE | | [K953179](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K953179.md) | CLM LARYNGOSCOPE | Penlon , Ltd. | Oct 6, 1995 | SESE | | [K951147](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW/K951147.md) | LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER | Leigh Med Tech, Inc. | Jun 8, 1995 | SESE | ## Top Applicants - Augustine Medical, Inc. — 5 clearances - Eastmed Enterprises, Inc. — 5 clearances - Minrad, Inc. — 3 clearances - Michael S. Upsher — 2 clearances - Wilson Greatbatch Technologies, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com