SINUSPRIME Dilation System
FDA 510(k) K201398 · Stryker Ent
510(k) numberK201398
Submission
- Device name
- SINUSPRIME Dilation System
- Applicant
- Stryker Ent
Plymouth, MN, US - Received
- May 28, 2020
- Decision date
- October 15, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRC – Instrument, Ent Manual Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230258 | BB 8 Sinus Dilation KitLRC · Traditional | Excelent, Inc. | 05/25/2023SE |
| K212774 | VenSure LightGuideLRC · Traditional | Intersect Ent. | 02/04/2022SE |
| K201115 | Next Generation Balloon Dilation SystemLRC · Traditional | Acclarent, Inc. | 08/27/2020SE |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon DeviceLRC · Traditional | Fiagon GmbH | 08/26/2020SE |
| K181546 | Dillard Nasal Balloon CatheterLRC · Traditional | Intuit Medical Products, LLC | 01/03/2020SE |
| K190525 | RELIEVA ULTIRRA Sinus Balloon CatheterLRC · Traditional | Acclarent, Inc. | 05/03/2019SE |
| K181838 | Sinusway Dilation SystemLRC · Traditional | 3nt Medical , Ltd. | 12/20/2018SE |
| K172737 | MESIRE - Balloon Sinus Dilatation SystemLRC · Traditional | M/S. Meril Life Sciences Private Limited | 12/12/2017SE |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty SystemLRC · Traditional | Acclarent, Inc. | 09/05/2017SE |
| K161698 | Relieva UltirraNav Sinus Balloon CatheterLRC · Traditional | Acclarent, Inc. | 10/24/2016SE |
More from Acclarent, Inc.
Questions and answers
When was SINUSPRIME Dilation System cleared by the FDA?
SINUSPRIME Dilation System (K201398) received a 510(k) decision of Substantially Equivalent on October 15, 2020, 140 days after the submission was received.
What is the product code of K201398?
The FDA product code is LRC – Instrument, Ent Manual Surgical, a Class I (low risk) device regulated under 21 CFR 874.4420.