Product Classification

• Device: catheter, suction, tracheobronchial, reprocessed
• Regulation Description: Ureteral stone dislodger.
• Definition: A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Anesthesiology
• Product Code: NQV
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 876.4680
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 1-189 ISO 4135 Fourth edition 2022-01
  Anaesthetic and respiratory equipment - Vocabulary

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc