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  3. Device Advice: Comprehensive Regulatory Assistance
  4. Overview of Device Regulation
  5. Classify Your Medical Device
  6. Medical Device Accessory Classification Request Granting Decisions
  1. Classify Your Medical Device

Medical Device Accessory Classification Request Granting Decisions

The FDA may either grant or decline an Accessory Classification Request. If the FDA grants an Accessory Classification Request, the FDA intends to provide a link to the classification order, on this page.

For more information about submitting requests and the FDA review timeline and decisions, see Medical Device Accessories.

Note: The columns labels in the table correspond to these descriptions.

  • Date: The date that the FDA granted the Accessory Classification Request.
  • Review Panel: The device classification panel.
  • Device Type: The regulatory description of the type of device.
  • Product Code: The 3-character product code associated with the device.
  • Associated Submission: The associated submission for the parent device.
  • Classification Order: The Q-submission number associated with the Accessory Classification Request, including a link to the PDF version of the classification order.
Date Review Panel Device Type Product Code Associated Submission Classification Order
04/26/2018 Orthopedic Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation QBO P150017 Cartiva Synthetic Cartilage Implant Q180170
04/16/2019 Gastroenterology-Urology Anchored esophageal sheath QGG P180024 BAROnova TransPyloric Shuttle/TransPyloric Shuttle Delivery Device Q181451
05/28/2020 Orthopedic Manual surgical instrument for appropriate patient selection for orthopedic implant QHG P160050 Barricaid Anular Closure Device Q190378
02/04/2020 Gastroenterology-Urology Laparoscopic gastrointestinal sizing tool QJN P100049 LINX Reflux Management System Q191422/S001
06/24/2020 Orthopedic Orthopedic manual surgical instrumentation for use with total disc replacement devices QLQ P170036 M6-C Artificial Cervical Disc Q200722
07/06/2020 Orthopedic Orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices QLR P110008 coflex Interlaminar Technology Q200824
07/10/2020 Ear, Nose, & Throat Field generator positioning device QLV K193502 Universal Headrest with Mounting Arm Q200834
11/22/2022 Gastroenterology-Urology Tether accessory for use in the gastrointestinal tract QUN K221608 NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether Q221569
04/13/2023 Cardiovascular Cardiovascular Delivery Catheter System Positioning and Stabilization Device QWA P220003 PASCAL Precision Transcatheter Valve Repair System Q230131
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