PosiSep X BAM Hemostat Dressing/Intranasal Splint
FDA 510(k) K220326 · Hemostasis, LLC
510(k) numberK220326
Submission
- Device name
- PosiSep X BAM Hemostat Dressing/Intranasal Splint
- Applicant
- Hemostasis, LLC
St. Paul, MN, US - Received
- February 4, 2022
- Decision date
- November 14, 2022
- 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 |
|---|---|---|---|
| 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 |
| K972922 | Vyker Silicone Epistaxis Catheter V-27030, Vyker Silicone Epistaxis Catheter Kit V-2703KEMX · Traditional | Interview Medical Technology Corp. | 10/08/1997SE |
More from Interview Medical Technology Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K234131 | Resolv Endoscopic Hemostat SystemQAU · Traditional | 07/26/2024SE |
| K210411 | PosiSep EAR Fragmentable Ear DressingNHB · Traditional | 05/05/2022SE |
| K142348 | OsteoSeal Bone HemostatMTJ · Traditional | 01/23/2015SE |
| K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal SplintLYA · Traditional | 03/27/2013SE |
| K122886 | Nexstat Plus and Nexfoam Plus Topical Hemostat DressingQSY · Special | 11/15/2012SE |
| K120958 | Posisep and Posisep X Hemostat DressingsQSY · Traditional | 07/25/2012SE |
| K102459 | Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeQSY · Traditional | 12/03/2010SE |
| K072900 | Excelarrest FoamQSY · Special | 10/26/2007SE |
| K070211 | Traumarrest and Bleedarrest Hemostatic Particles and FoamQSY · Traditional | 04/05/2007SE |
Questions and answers
When was PosiSep X BAM Hemostat Dressing/Intranasal Splint cleared by the FDA?
PosiSep X BAM Hemostat Dressing/Intranasal Splint (K220326) received a 510(k) decision of Substantially Equivalent on November 14, 2022, 283 days after the submission was received.
What is the product code of K220326?
The FDA product code is EMX – Balloon, Epistaxis, a Class I (low risk) device regulated under 21 CFR 874.4100.