Clarus Video Airway Endoscope, Models 30000-V and 30003-V
FDA 510(k) K082038 · Clarus Medical, LLC
510(k) numberK082038
Submission
- Device name
- Clarus Video Airway Endoscope, Models 30000-V and 30003-V
- Applicant
- Clarus Medical, LLC
Golden Valley, MN, US - Received
- July 17, 2008
- Decision date
- April 28, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5730
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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|---|---|---|---|
| K251794 | Tenax® Laser Resistant Endotracheal TubeBTR · Traditional | Bryan Medical, Inc. | 09/03/2026SE |
| K253437 | Spiro-VISTABTR · Traditional | Spiro Robotics | 06/12/2026SE |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal…BTR · Traditional | Covidien, LLC | 10/06/2025SE |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley…BTR · Traditional | Covidien, LLC | 09/25/2025SE |
| K243579 | AeroJet Ventilation CatheterBTR · Traditional | Pipeline Medical Products, LLC | 08/13/2025SE |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer…BTR · Special | William Cook Europe Aps | 06/11/2025SE |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…BTR · Traditional | Flexicare Medical Limited. | 05/20/2025SE |
| K242495 | LMA Fastrach ETT SUBTR · Traditional | Teleflex Medical | 04/29/2025SE |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch…BTR · Traditional | Teleflex Incorporated | 02/11/2025SE |
| K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440…BTR · Traditional | Covidien, LLC | 05/20/2024SE |
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| K200925 | Clarus Peel-Away Introducer SheathGWG · Traditional | 03/18/2021SE |
| K040919 | Nucleotome Probe Set, Model 21200HRX · Traditional | 06/01/2004SE |
| K040424 | Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…GEX · Traditional | 05/11/2004SE |
| K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160GEX · Traditional | 11/05/2002SE |
| K021848 | Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160GEX · Traditional | 09/03/2002SE |
| K011454 | Spine Scope, Model 2180HRX · Traditional | 12/13/2001SE |
Questions and answers
When was Clarus Video Airway Endoscope, Models 30000-V and 30003-V cleared by the FDA?
Clarus Video Airway Endoscope, Models 30000-V and 30003-V (K082038) received a 510(k) decision of Substantially Equivalent on April 28, 2009, 285 days after the submission was received.
What is the product code of K082038?
The FDA product code is BTR – Tube, Tracheal (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5730.