Custom Nasal Splint
FDA 510(k) K972082 · Boston Medical Products, Inc.
510(k) numberK972082
Submission
- Device name
- Custom Nasal Splint
- Applicant
- Boston Medical Products, Inc.
Westborough, MA, US - Received
- June 4, 1997
- Decision date
- July 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYA – Splint, Intranasal Septal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4780
- Specialty
- Ear, Nose, Throat
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| K213153 | SPIWay Endonasal Access GuideLYA · Special | Spiway, LLC | 10/27/2021SE |
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| K181696 | ChitoZolveLYA · Traditional | Gyrus Acmi, Inc. | 11/30/2018SE |
| K180141 | SPIWay Endonasal Access GuideLYA · Special | Spiway, LLC | 02/16/2018SE |
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| K172179 | Chitogel Endoscopic Sinus Surgery KitLYA · Traditional | Chitogel, Ltd. | 10/17/2017SE |
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| K141816 | HemoporeLYA · Traditional | Polyganics B.V., | 10/23/2014SE |
More from Polyganics B.V.,
| 510(k) | Device | Decision |
|---|---|---|
| K091135 | Rutter Supra Stomal StentsFWN · Traditional | 09/14/2009SE |
| K972317 | Montgomery Thyroplasty Implant SystemMIX · Traditional | 09/18/1997SE |
| K972459 | Rhinocell Nasal PackingsEMX · Traditional | 08/04/1997SE |
| K972096 | Bivalve Nasal SplintLYA · Traditional | 07/15/1997SE |
| K972078 | Post-Stop Epistaxis CatheterEMX · Traditional | 07/10/1997SE |
| K972092 | Nasal Airway SplintLYA · Traditional | 07/08/1997SE |
| K972151 | Doyle Combo Nasal Airway SplintLYA · Traditional | 07/07/1997SE |
| K972060 | Nasal Septal ButtonLFB · Traditional | 07/03/1997SE |
| K972077 | Epi-Stop Epistaxis CatheterEMX · Traditional | 06/26/1997SE |
| K972076 | Epi-Max Epistaxis CatheterEMX · Traditional | 06/26/1997SE |
Questions and answers
When was Custom Nasal Splint cleared by the FDA?
Custom Nasal Splint (K972082) received a 510(k) decision of Substantially Equivalent on July 3, 1997, 29 days after the submission was received.
What is the product code of K972082?
The FDA product code is LYA – Splint, Intranasal Septal, a Class I (low risk) device regulated under 21 CFR 874.4780.