Merocel(R) Turbinate Glove and Septal Splint
FDA 510(k) K935658 · Merocel Corp.
510(k) numberK935658
Submission
- Device name
- Merocel(R) Turbinate Glove and Septal Splint
- Applicant
- Merocel Corp.
Mystic, CT, US - Received
- November 24, 1993
- Decision date
- March 4, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code LYA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243655 | TurbAlignLYA · Traditional | Spirair, Inc. | 07/11/2025SE |
| 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 |
| K181696 | ChitoZolveLYA · Traditional | Gyrus Acmi, Inc. | 11/30/2018SE |
| 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 |
More from Polyganics B.V.,
| 510(k) | Device | Decision |
|---|---|---|
| K954919 | Merocel Soft Wound DressingKMF · Traditional | 11/14/1995SN |
| K953072 | Merocel Vaginal PackEFQ · Traditional | 09/12/1995SE |
| K953013 | Merocel Reinforced Silicone SheetsKHJ · Traditional | 08/29/1995SE |
| K943718 | Epistat-Ii Nasal CatheterEMX · Traditional | 09/16/1994SE |
| K940572 | Merocel(R) Wound Dressing (with Hemostatic Claim)KMF · Traditional | 06/07/1994SE |
| K933152 | Merocel MerosplintLYA · Traditional | 08/17/1993SE |
| K931565 | Merocel Wound DressingKMF · Traditional | 08/06/1993SN |
| K920394 | Merocel Epistacis KitEMX · Traditional | 03/18/1993SE |
| K910463 | Merocel(R) Laser-Guard(Tm)BTR · Traditional | 04/06/1992SE |
Questions and answers
When was Merocel(R) Turbinate Glove and Septal Splint cleared by the FDA?
Merocel(R) Turbinate Glove and Septal Splint (K935658) received a 510(k) decision of Substantially Equivalent on March 4, 1994, 100 days after the submission was received.
What is the product code of K935658?
The FDA product code is LYA – Splint, Intranasal Septal, a Class I (low risk) device regulated under 21 CFR 874.4780.