Rhinocell Nasal Packings
FDA 510(k) K972459 · Boston Medical Products, Inc.
510(k) numberK972459
Submission
- Device name
- Rhinocell Nasal Packings
- Applicant
- Boston Medical Products, Inc.
Westborough, MA, US - Received
- July 1, 1997
- Decision date
- August 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K091135 | Rutter Supra Stomal StentsFWN · Traditional | 09/14/2009SE |
| K972317 | Montgomery Thyroplasty Implant SystemMIX · Traditional | 09/18/1997SE |
| 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 |
| K972082 | Custom Nasal SplintLYA · Traditional | 07/03/1997SE |
| 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 Rhinocell Nasal Packings cleared by the FDA?
Rhinocell Nasal Packings (K972459) received a 510(k) decision of Substantially Equivalent on August 4, 1997, 34 days after the submission was received.
What is the product code of K972459?
The FDA product code is EMX – Balloon, Epistaxis, a Class I (low risk) device regulated under 21 CFR 874.4100.