Meropack Bioresorbable Nasal Packing and Sinus Stent
FDA 510(k) K041381 · Medtronic Xomed, Inc.
510(k) numberK041381
Submission
- Device name
- Meropack Bioresorbable Nasal Packing and Sinus Stent
- Applicant
- Medtronic Xomed, Inc.
Jacksonville, FL, US - Received
- May 25, 2004
- Decision date
- September 10, 2004
- 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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| K230142 | Epi-Stop Nasal Gel/epistaxis packLYA · Traditional | Biomed Ent, Inc. | 03/22/2023SE |
| K213153 | SPIWay Endonasal Access GuideLYA · Special | Spiway, LLC | 10/27/2021SE |
| K202623 | Novapak Nasal Sinus Packing and StentLYA · Traditional | Medtronic Xomed | 12/08/2020SE |
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| K180141 | SPIWay Endonasal Access GuideLYA · Special | Spiway, LLC | 02/16/2018SE |
| K170913 | Composite Removable Sinus Stent SystemLYA · Traditional | Sts Medical | 12/15/2017SE |
| K172179 | Chitogel Endoscopic Sinus Surgery KitLYA · Traditional | Chitogel, Ltd. | 10/17/2017SE |
| K153686 | SPIWay Endonasal Access GuideLYA · Special | Spiway, LLC | 01/28/2016SE |
| K141816 | HemoporeLYA · Traditional | Polyganics B.V., | 10/23/2014SE |
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| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeETN · Special | 10/26/2023SE |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)ETN · Traditional | 08/30/2023SE |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM…ETN · Traditional | 03/21/2022SE |
| K210841 | NuVent Eustachian Tube Dilation BalloonPNZ · Traditional | 08/16/2021SE |
| K202623 | Novapak Nasal Sinus Packing and StentLYA · Traditional | 12/08/2020SE |
| K200759 | NIM Vital, Nerve Integrity MonitorGWF · Traditional | 10/28/2020SE |
| K173855 | Sharpsite AC Rigid EndsocopeEOB · Traditional | 04/20/2018SE |
| K152121 | NuVent EM Sinus Dilation SystemLRC · Traditional | 12/01/2015SE |
Questions and answers
When was Meropack Bioresorbable Nasal Packing and Sinus Stent cleared by the FDA?
Meropack Bioresorbable Nasal Packing and Sinus Stent (K041381) received a 510(k) decision of Substantially Equivalent on September 10, 2004, 108 days after the submission was received.
What is the product code of K041381?
The FDA product code is LYA – Splint, Intranasal Septal, a Class I (low risk) device regulated under 21 CFR 874.4780.