510(k) K220326
- Device
- PosiSep X BAM Hemostat Dressing/Intranasal Splint
- Applicant
- Hemostasis, LLC
- 510(k) number
- K220326
- Product code
- EMX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-14
- Date received
- 2022-02-04
- Regulation
- 874.4100
- Classification name
- Balloon, Epistaxis
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lakshmi Ganesh Bollina
- Address
- 5000 Township Pkwy. St. Paul MN US 55110 55110
FDA Registration Numbers#
- 3002858762
- 3012358417
- 3015967359
- 1219071
- 3015821396
- 3016678045
- 2183744
- 8043396
- 3003418325
- 1836161
- 1060680
- 1220477
- 3008719017
- 3014656749
- 1043214
- 2320762
- 3014334038
- 1450662
- 3015335956
- 1219313
- 1423662
- 3007225047
- 8043838
- 1219795
- 3003790304
- 8022978
- 1037007
- 1055236
- 3023464160
- 3019543072
- 3006345872
- 1225532
- 3008812251
- 9680271
- 1824231
- 1052728
- 3011050570
- 3009403363
- 8030607
- 3010610457
- 1643264
- 9612501
- 1211998
- 3007735241
- 1043534
- 3008174904
- 3012307300
- 3011137372
- 3009134882
- 3013671177
- 3013399629
- 1045254
- 1054241
- 3006787036
- 2245304
- 1928237
- 1526534
- 3001644167
- 3006524618
- 3004365956
Source Documents#
Other 510(k) Records For Product Code EMX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041446 | NASALCEASE | Les Laboratorires Brothier, S.A. | 2004-07-01 |
| K000108 | RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 | Bhk Holding | 2000-05-23 |
| K993362 | HYLASINE | Biomatrix, Inc. | 2000-03-13 |
| K983276 | HYDROFERA BACTERISTATIC NASAL DRESSING | Hydrofera, LLC | 1999-09-14 |
| K982731 | MEROGEL NASAL DRESSING AND SINUS STENT | Xomed, Inc. | 1999-02-02 |
| K984069 | ENTAXIS NASAL PACKING | Les Laboratorires Brothier, S.A. | 1999-01-25 |
| K981966 | NOSEBLEED NOSECLIP | Michael M. Knott, M.D. | 1998-08-14 |
| K973656 | DISPOSABLE SILICONE EPISTAXIS CATHETER | Specialty Surgical Products, Inc. | 1997-11-18 |
| K973085 | ULTRACELL PACKING WITH SLEEVE | Ultracell Medical Technologies, Inc. | 1997-11-18 |
| K972922 | VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K | Interview Medical Technology Corp. | 1997-10-08 |
| K972459 | RHINOCELL NASAL PACKINGS | Boston Medical Products, Inc. | 1997-08-04 |
| K972078 | POST-STOP EPISTAXIS CATHETER | Boston Medical Products, Inc. | 1997-07-10 |
| K972077 | EPI-STOP EPISTAXIS CATHETER | Boston Medical Products, Inc. | 1997-06-26 |
| K972076 | EPI-MAX EPISTAXIS CATHETER | Boston Medical Products, Inc. | 1997-06-26 |
| K971411 | DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K | Bentec Medical, Inc. | 1997-06-03 |