Fox Post Nasal Balloon Catheter
FDA 510(k) K841040 · Inmed Corp.
510(k) numberK841040
Submission
- Device name
- Fox Post Nasal Balloon Catheter
- Applicant
- Inmed Corp.
Mchenry, IL, US - Received
- March 12, 1984
- Decision date
- August 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EMX – Balloon, Epistaxis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4100
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EMX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220326 | PosiSep X BAM Hemostat Dressing/Intranasal SplintEMX · Traditional | Hemostasis, LLC | 11/14/2022SE |
| K041446 | NasalceaseEMX · Traditional | Les Laboratorires Brothier, S.A. | 07/01/2004SE |
| K000108 | Rapid Rhino-Anterior 90MM, Model Rr-A 90, Rapid Rhino-Posterior 100MM, Model Rr-P 100EMX · Traditional | Bhk Holding | 05/23/2000SE |
| K993362 | HylasineEMX · Traditional | Biomatrix, Inc. | 03/13/2000SE |
| K983276 | Hydrofera Bacteristatic Nasal DressingEMX · Traditional | Hydrofera, LLC | 09/14/1999SE |
| K982731 | Merogel Nasal Dressing and Sinus StentEMX · Traditional | Xomed, Inc. | 02/02/1999SE |
| K984069 | Entaxis Nasal PackingEMX · Traditional | Les Laboratorires Brothier, S.A. | 01/25/1999SE |
| K981966 | Nosebleed NoseclipEMX · Traditional | Michael M. Knott, M.D. | 08/14/1998SE |
| K973656 | Disposable Silicone Epistaxis CatheterEMX · Traditional | Specialty Surgical Products, Inc. | 11/18/1997SE |
| K973085 | Ultracell Packing with SleeveEMX · Traditional | Ultracell Medical Technologies, Inc. | 11/18/1997SE |
More from Ultracell Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862672 | Esophageal Stethoscope with ThermistorBZT · Traditional | 10/27/1986SE |
| K853162 | Sterile Nasopharyngeal AirwayBTQ · Traditional | 08/06/1985SE |
| K850335 | Ureteroscopy CatheterKOD · Traditional | 03/12/1985SE |
| K850248 | Disposable Guedel AirwayCAE · Traditional | 03/12/1985SE |
| K850152 | Preconnected Urethral Catheter Tray · Traditional | 03/12/1985SE |
| K844801 | Ultra External CatheterKNX · Traditional | 01/15/1985SE |
| K842301 | Disposable Latex BandageKGX · Traditional | 11/05/1984SE |
| K842866 | Urethral Catheterization TrayKOD · Traditional | 09/10/1984SE |
| K842865 | Esophageal StethoscopeBZW · Traditional | 08/15/1984SE |
| K841037 | Penrose Drains · Traditional | 04/25/1984SE |
Questions and answers
When was Fox Post Nasal Balloon Catheter cleared by the FDA?
Fox Post Nasal Balloon Catheter (K841040) received a 510(k) decision of Substantially Equivalent on August 17, 1984, 158 days after the submission was received.
What is the product code of K841040?
The FDA product code is EMX – Balloon, Epistaxis, a Class I (low risk) device regulated under 21 CFR 874.4100.