Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OGPCricothyrotomy Kit2Product Code
- OGVTracheostomy Cleaning Tray2Product Code
- OGWTracheostomy Kit2Product Code
- MYBPillow, Cervical (For Mild Sleep Apnea)2Product Code
- EPNPump, Nebulizer, Manual1Product Code
- EPPSplint, Nasal1Product Code
- ETFUnit, Examining/Treatment, Ent1Product Code
- EWTDevice, Antichoke, Suction3Product Code
- EWWDevice, Antichoke, Tongs3Product Code
- JPWPump, Nebulizer, Electrically Powered1Product Code
- KCJApplicator, Ent1Product Code
- KCLBlower, Powder, Ent1Product Code
- KCMDropper, Ent1Product Code
- KCNEar Wick1Product Code
- KCONasal Spray, Ent Delivery1Product Code
- KCPSyringe, Ent1Product Code
- KMAIrrigator, Powered Nasal1Product Code
- KTHDevice, Anti-Stammering1Product Code
- LRDApplicator, Ent Drug1Product Code
- PKAExternal Upper Esophageal Sphincter (Ues) Compression Device2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Tracheostomy Kit
- Page Type
- Product Code
- Definition
- This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
- Physical State
- This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Technical Method
- This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Target Area
- This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Regulation Medical Specialty
- Anesthesiology
- Review Panel
- Ear, Nose, Throat
- Submission Type
- Enforcement Discretion
- Device Classification
- Class 2
- Regulation Number
- 868.5800
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 868.5800 Tracheostomy tube and tube cuff
§ 868.5800 Tracheostomy tube and tube cuff.
(a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.
(b) Classification. Class II.
[51 FR 40389, Nov. 6, 1986]