BD Surgiphor Antimicrobial Irrigation System
FDA 510(k) clearance K213616 · decided 2022-03-23
Clearance details
- K-number
- K213616
- Device name
- BD Surgiphor Antimicrobial Irrigation System
- Applicant
- Becton, Dickinson and Company
- Decision
- Substantially Equivalent
- Date received
- 2021-11-15
- Decision date
- 2022-03-23
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- FQH
- Device class
- 2
- Regulation number
- 880.5475
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| BD Surgiphor™ Antimicrobial Irrigation System (910110) (K253996) | Becton, Dickinson and Company (BD) | 2026-02-25 |
| BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (K253445) | Bd | 2026-02-20 |
| ERBEJET® 2 System (K231023) | Erbe Elektromedizin GmbH | 2023-06-15 |
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| VERSAJET Hydrosurgery System (III) (K220964) | Smith & Nephew Medical Limited | 2023-05-16 |
| BD Surgiphor™ Antimicrobial Irrigation System (K221504) | Bd | 2022-10-14 |
| Irrisept Antimicrobial Wound Lavage (K222804) | Irrimax Corporation | 2022-09-22 |
| IRRIGO Wound Wash Jet System (K210987) | Inopro, Inc. | 2022-05-31 |
| Irrisept Antimicrobial Wound Lavage (K210536) | Irrimax Corporation | 2021-05-28 |
| Irrisept Wound Debridement and Cleansing System (K202222) | Irrimax Corporation | 2020-12-14 |
| SURGIPHOR Wound Irrigation System (K202071) | Orthophor, LLC | 2020-10-23 |
| Bactisure Wound Lavage (K192349) | Next Science, LLC | 2020-01-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BD ONCLARITY HPV ASSAY (P160037/S022) | Becton, Dickinson and Company | 2025-08-25 |
| BD Onclarity HPV Assay (P160037/S023) | Becton, Dickinson and Company | 2025-07-02 |
| Onclarity HPV Assay (P160037/S021) | Becton, Dickinson and Company | 2025-03-12 |
| BD Onclarity HPV Assay (P160037/S020) | Becton, Dickinson and Company | 2024-11-05 |
| BD Onclarity HPV Assay (P160037/S017) | Becton, Dickinson and Company | 2024-05-14 |
| BD Onclarity HPV Assay (P160037/S019) | Becton, Dickinson and Company | 2024-04-18 |
| BD Onclarity HPV Assay (P160037/S018) | Becton, Dickinson and Company | 2023-11-20 |
| BD Onclarity HPV (P160037/S016) | Becton, Dickinson and Company | 2023-11-15 |