FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTISAN PULSE LAVAGE SYSTEM
K Number: K972551
·
Decision Oct 29, 1997
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
52
Applicant Total
373
Review Days
113
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ARTISAN PULSE LAVAGE SYSTEM
- K Number
- K972551
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5475
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica Corp.
- Date Received
- July 8, 1997
- Decision Date
- October 29, 1997
- Product Code
- FQH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FQH | Lavage, Jet | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FQH), ordered by most recent decision date.
BD Surgiphor Antimicrobial Irrigation System (910110)
FDA 510(k)
FDA Class 2
·General Hospital
BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)
FDA 510(k)
FDA Class 2
·General Hospital
ERBEJET® 2 System
FDA 510(k)
FDA Class 2
·General Hospital
Armis VeriCyn Wound Wash
FDA 510(k)
FDA Class 2
·General Hospital
VERSAJET Hydrosurgery System (III)
FDA 510(k)
FDA Class 2
·General Hospital
BD Surgiphor Antimicrobial Irrigation System
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Howmedica Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K983528 | MICRO DYNAMIC MESH | Dec 23, 1998 | Substantially Equivalent |
| K983404 | TYPE 3 FEMORAL COMPONENTS | Dec 22, 1998 | Substantially Equivalent |
| K980925 | DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980632 | DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K983419 | HOFFMANN II MIAMI POST | Nov 25, 1998 | Substantially Equivalent |
| K982958 | ZETA MULTIZONE LOCKING NAIL SYSTEM | Nov 20, 1998 | Substantially Equivalent |
| K982873 | ZETA MULTIZONE SCN LOCKING NAIL | Oct 21, 1998 | Substantially Equivalent |
| K982531 | HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM | Oct 16, 1998 | Substantially Equivalent |