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|