510(k) K972069
- Device
- STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK
- Applicant
- STRYKER INSTRUMENTS
- 510(k) number
- K972069
- Product code
- FQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-07-29
- Date received
- 1997-06-03
- 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
- TAMMMY LOUNDS
- Address
- 4100 E. Milham Ave. Kalamazoo MI US 49001 49001
FDA Registration Numbers#
- 1718850
- 3007177643
- 3002808022
- 2020601
- 3005173255
- 3013557562
- 3022320321
- 1060680
- 3009762450
- 3012494290
- 3006535925
- 2649614
- 3008788129
- 3007829657
- 3015542154
- 2025102
- 3005083075
- 2242352
- 3010531069
- 3007225330
- 3014620201
- 2648623
- 2245304
- 3012797688
- 3010305275
- 3042172872
- 2528981
- 3003814961
- 2648920
- 3005941719
- 3004365956
- 1058584
- 2648666
- 3021784063
- 8043484
- 3010536692
- 3007502289
- 3012130008
- 1319660
- 3014351477
- 3004380247
- 1054811
- 1020279
- 3007125392
- 3015967359
- 3011137372
- 1423507
- 3032611331
- 1043214
- 3010701807
- 3011683674
- 3010361494
- 3038472982
- 3007997036
- 3003903031
- 3010273872
- 3010400865
- 3007594734
- 3004837686
- 2244478
- 8044091
- 3004464325
- 3002907620
- 3002807523
- 1055236
- 3013530403
- 3009217531
- 1018470
- 3003477135
- 9615063
- 3020745223
- 1526350
- 3005099803
- 3035366890
- 3012649202
- 9610614
- 1417411
- 1724474
- 1036836
- 1424263
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases