Epistat-Ii Nasal Catheter
FDA 510(k) K943718 · Merocel Corp.
510(k) numberK943718
Submission
- Device name
- Epistat-Ii Nasal Catheter
- Applicant
- Merocel Corp.
Mystic, CT, US - Received
- August 1, 1994
- Decision date
- September 16, 1994
- 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 |
|---|---|---|
| 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 |
| K940572 | Merocel(R) Wound Dressing (with Hemostatic Claim)KMF · Traditional | 06/07/1994SE |
| K935658 | Merocel(R) Turbinate Glove and Septal SplintLYA · Traditional | 03/04/1994SE |
| 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 Epistat-Ii Nasal Catheter cleared by the FDA?
Epistat-Ii Nasal Catheter (K943718) received a 510(k) decision of Substantially Equivalent on September 16, 1994, 46 days after the submission was received.
What is the product code of K943718?
The FDA product code is EMX – Balloon, Epistaxis, a Class I (low risk) device regulated under 21 CFR 874.4100.