Microtek Intranasal Splint
FDA 510(k) K862496 · Microtek Medical, Inc.
510(k) numberK862496
Submission
- Device name
- Microtek Intranasal Splint
- Applicant
- Microtek Medical, Inc.
Columbus, MS, US - Received
- July 1, 1986
- Decision date
- July 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EPP – Splint, Nasal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5800
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EPP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942158 | Aquaplast Nasal Splints, Precut Silver Splint Patterns and Splint KitsEPP · Traditional | Wfr/Aquaplast Corp. | 07/29/1994SE |
| K942724 | External Nasal SplintEPP · Traditional | Micromed Development Corp. | 07/08/1994SE |
| K895502 | Microtek Reuter-Style Bi-Valve Intranasal SplintEPP · Traditional | Microbio-Medics, Inc. | 12/08/1989SE |
| K890599 | Hood Nasal SplintEPP · Traditional | Hood Laboratories | 03/17/1989SE |
| K882244 | Richards Thermoplastic Dorsal Nasal SplintEPP · Traditional | Richards Medical Co., Inc. | 06/23/1988SE |
| K872905 | American Nasal SpongeEPP · Traditional | American Silk Sutures, Inc. | 09/04/1987SE |
| K864933 | 'Exmoor' Shah & Mackay Nasal SplintsEPP · Traditional | Exmoor Plastics , Ltd. | 03/04/1987SE |
| K864932 | 'Exmoor' Cawood Nasal SplintsEPP · Traditional | Exmoor Plastics , Ltd. | 03/04/1987SE |
| K864930 | 'Exmoor' Atkins Nasal SplintEPP · Traditional | Exmoor Plastics , Ltd. | 03/04/1987SE |
| K864934 | 'Exmoor' Shah Silicone DiscsEPP · Traditional | Exmoor Plastics , Ltd. | 01/28/1987SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II…LHI · Traditional | 09/16/2025SE |
| K110358 | Venodyne V810JOW · Traditional | 05/05/2011SE |
| K102971 | Freedomaire III Surgical Helmet System Model 10322STKFYA · Traditional | 02/23/2011SE |
| K062899 | Microtek Medical Surgical Gown/TogaFYA · Traditional | 01/25/2007SE |
| K060200 | Microtek Medical Warming DrapeKKX · Traditional | 05/31/2006SE |
| K050322 | Microtek Equipment DrapesKKX · Traditional | 05/17/2005SE |
| K022903 | ChillbusterDWJ · Traditional | 11/27/2002SE |
| K020956 | Vivosonic Dianostic Ultrasound Imaging Coupling MediaMUI · Traditional | 05/16/2002SE |
| K011318 | Venodyne DVT Advantage PlusJOW · Traditional | 10/25/2001SE |
| K001802 | Venodyne DVT Advantage Model 610JOW · Traditional | 01/09/2001SE |
Questions and answers
When was Microtek Intranasal Splint cleared by the FDA?
Microtek Intranasal Splint (K862496) received a 510(k) decision of Substantially Equivalent on July 14, 1986, 13 days after the submission was received.
What is the product code of K862496?
The FDA product code is EPP – Splint, Nasal, a Class I (low risk) device regulated under 21 CFR 874.5800.