510(k) K970916
- Device
- H.V. PULSE LAVAGE (L31 SERIES)
- Applicant
- GLOBAL MEDICAL PRODUCTS, INC.
- 510(k) number
- K970916
- Product code
- FQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-06-20
- Date received
- 1997-03-12
- Regulation
- 880.5475
- Classification name
- Lavage, Jet
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TONYA BALABAN
- Address
- 1725 S. Rainbow Blvd., #25 Las Vegas NV US 89146 89146
FDA Registration Numbers#
- 3017540705
- 2027148
- 2029275
- 8043750
- 2528981
- 2242352
- 2244478
- 3009125070
- 1526350
- 1423662
- 3006535925
- 3004986960
- 3010400865
- 1417411
- 3032611331
- 1423395
- 8044091
- 1000121056
- 2184009
- 2649614
- 2648623
- 3004380247
- 3017252917
- 3007502289
- 2648920
- 2020601
- 3007997036
- 3002907620
- 3012964172
- 2011171
- 3005706359
- 3012497308
- 3005083075
- 1054241
- 2245304
- 1423507
- 2183613
- 1225687
- 1018470
- 3010361494
- 3010531069
- 3031571797
- 1526439
- 9617155
- 3007594734
- 9610711
- 9616684
- 1417519
- 3004837686
- 3007177643
- 3043622938
- 3010273872
- 3003955307
- 2025102
- 3003587189
- 3010701807
- 3003903031
- 1422634
- 1055236
- 1020279
- 3008500478
- 1036836
- 3003814961
- 1649518
- 1057196
- 3014258951
- 3010536692
- 1649139
- 1526534
- 3020745223
- 3042172872
- 3004365956
- 3010872518
- 3037027197
- 3002807315
- 3015967359
- 2435119
- 3016678045
- 9617429
Source Documents#
Other 510(k) Records For Product Code FQH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253996 | BD Surgiphor™ Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | 2026-02-25 |
| K253445 | BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) | Bd | 2026-02-20 |
| K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | 2023-06-15 |
| K220759 | Armis VeriCyn Wound Wash | Armis Biopharma, Inc. | 2023-05-25 |
| K220964 | VERSAJET Hydrosurgery System (III) | Smith & Nephew Medical Limited | 2023-05-16 |
| K221504 | BD Surgiphor™ Antimicrobial Irrigation System | Bd | 2022-10-14 |
| K222804 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2022-09-22 |
| K210987 | IRRIGO Wound Wash Jet System | Inopro, Inc. | 2022-05-31 |
| K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022-03-23 |
| K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021-05-28 |
| K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | 2020-12-14 |
| K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020-10-23 |
| K192349 | Bactisure Wound Lavage | Next Science, LLC | 2020-01-23 |
| K161165 | Next Science Irrigation Solution | Next Science, LLC | 2016-09-07 |
| K143115 | The VersaJet II Hydrosurgery System | Smith & Nephew, Inc. | 2015-07-15 |
Legacy Summary#
summary
FDA Review#
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