PosiSep X BAM Hemostat Dressing/Intranasal Splint
FDA 510(k) clearance K220326 · decided 2022-11-14
Clearance details
- K-number
- K220326
- Device name
- PosiSep X BAM Hemostat Dressing/Intranasal Splint
- Applicant
- Hemostasis, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-02-04
- Decision date
- 2022-11-14
- Days to decision
- 283 days
- Clearance type
- Traditional
- Product code
- EMX
- Device class
- 1
- Regulation number
- 874.4100
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NASALCEASE (K041446) | Les Laboratorires Brothier, S.A. | 2004-07-01 |
| RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 (K000108) | Bhk Holding | 2000-05-23 |
| HYLASINE (K993362) | Biomatrix, Inc. | 2000-03-13 |
| HYDROFERA BACTERISTATIC NASAL DRESSING (K983276) | Hydrofera, LLC | 1999-09-14 |
| MEROGEL NASAL DRESSING AND SINUS STENT (K982731) | Xomed, Inc. | 1999-02-02 |
| ENTAXIS NASAL PACKING (K984069) | Les Laboratorires Brothier, S.A. | 1999-01-25 |
| NOSEBLEED NOSECLIP (K981966) | Michael M. Knott, M.D. | 1998-08-14 |
| DISPOSABLE SILICONE EPISTAXIS CATHETER (K973656) | Specialty Surgical Products, Inc. | 1997-11-18 |
| ULTRACELL PACKING WITH SLEEVE (K973085) | Ultracell Medical Technologies, Inc. | 1997-11-18 |
| VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K (K972922) | Interview Medical Technology Corp. | 1997-10-08 |
| RHINOCELL NASAL PACKINGS (K972459) | Boston Medical Products, Inc. | 1997-08-04 |
| POST-STOP EPISTAXIS CATHETER (K972078) | Boston Medical Products, Inc. | 1997-07-10 |
Recalls involving this device
No recalls on record reference this clearance.