EMX — Balloon, Epistaxis Class I
FDA product code EMX covers "Balloon, Epistaxis", a Class I medical device regulated under 21 CFR 874.4100. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EMX
- Device Class
- Class I
- Regulation Number
- 874.4100
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220326 | hemostasis | PosiSep X BAM Hemostat Dressing/Intranasal Splint | November 14, 2022 |
| K041446 | les laboratorires brothier | NASALCEASE | July 1, 2004 |
| K000108 | bhk holding | RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR- | May 23, 2000 |
| K993362 | biomatrix | HYLASINE | March 13, 2000 |
| K983276 | hydrofera | HYDROFERA BACTERISTATIC NASAL DRESSING | September 14, 1999 |
| K982731 | xomed | MEROGEL NASAL DRESSING AND SINUS STENT | February 2, 1999 |
| K984069 | les laboratorires brothier | ENTAXIS NASAL PACKING | January 25, 1999 |
| K981966 | michael m. knott, m.d | NOSEBLEED NOSECLIP | August 14, 1998 |
| K973656 | specialty surgical products | DISPOSABLE SILICONE EPISTAXIS CATHETER | November 18, 1997 |
| K973085 | ultracell medical technologies | ULTRACELL PACKING WITH SLEEVE | November 18, 1997 |
| K972922 | interview medical technology | VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT | October 8, 1997 |
| K972459 | boston medical products | RHINOCELL NASAL PACKINGS | August 4, 1997 |
| K972078 | boston medical products | POST-STOP EPISTAXIS CATHETER | July 10, 1997 |
| K972077 | boston medical products | EPI-STOP EPISTAXIS CATHETER | June 26, 1997 |
| K972076 | boston medical products | EPI-MAX EPISTAXIS CATHETER | June 26, 1997 |
| K971411 | bentec medical | DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CAT | June 3, 1997 |
| K971000 | invotec international | EPISTAXIS NASAL PACK | May 14, 1997 |
| K964113 | m-pact worldwide management | IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY | November 7, 1996 |
| K963856 | rand scientific | RAND NASAL PACKING | October 18, 1996 |
| K962133 | shippert medical technologies | EXPANDACELL INJECTO-PAK | August 1, 1996 |