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U.S. FDA Medical Device Sinus Irrigator Requirements

FDA Medical Device Definition: An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.

Registrar Corp assists Sinus Irrigator companies with:

  • FDA Sinus Irrigator Establishment Registration
  • FDA Sinus Irrigator Listing
  • FDA Sinus Irrigator Label Requirements and Exceptions
  • FDA Sinus Irrigator Import Information
  • FDA Sinus Irrigator Detentions (Sinus Irrigator Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Sinus Irrigator Manufacturers (Sinus Irrigator Suppliers)
       - Sinus Irrigator Distributors
       - Sinus Irrigator Processors
       - Sinus Irrigator Repackers
       - Sinus Irrigator Relabelers
       - Sinus Irrigator Exporters
       - Sinus Irrigator Importers
For more information about Sinus Irrigator Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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