Norton Endotracheal
FDA 510(k) K771197 · V. Mueller O.V. Baxter Healthcare Corp.
510(k) numberK771197
Submission
- Device name
- Norton Endotracheal
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
Mchenry, IL, US - Received
- July 1, 1977
- Decision date
- August 16, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code BTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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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| K803292 | Field Suction DissectorGDI · Traditional | 01/29/1981SE |
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| K771302 | Pfister-Schwartz Stone RetrieverFGO · Traditional | 08/02/1977SE |
| K770959 | Bougie, Filiform, JacksonKBI · Traditional | 06/14/1977SE |
| K770280 | Cord, Electrosurgical-Sterile & Dispos.KNS · Traditional | 04/15/1977SE |
| K760851 | Converse Altar RetractorKAL · Traditional | 03/10/1977SE |
| K761242 | Teflon Coated Resectoscope SheathFJL · Traditional | 12/16/1976SE |
| K760273 | LithotriteFGK · Traditional | 12/06/1976SE |
| K760189 | Stopcock, WaterlineFAJ · Traditional | 12/02/1976SE |
| K760184 | Element, WorkingFDC · Traditional | 12/02/1976SE |
Questions and answers
When was Norton Endotracheal cleared by the FDA?
Norton Endotracheal (K771197) received a 510(k) decision of Substantially Equivalent on August 16, 1977, 46 days after the submission was received.
What is the product code of K771197?
The FDA product code is BTR – Tube, Tracheal (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5730.