FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO-AIRE PULSE LAVAGE
K Number: K874504
·
Decision Dec 29, 1987
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
52
Applicant Total
40
Review Days
57
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
- MICRO-AIRE PULSE LAVAGE
- K Number
- K874504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5475
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Micro-Aire Surgical Instruments, Inc.
- Date Received
- November 2, 1987
- Decision Date
- December 29, 1987
- 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 Micro-Aire Surgical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K904949 | A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS | Nov 26, 1990 | Substantially Equivalent |
| K903713 | OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 | Sep 14, 1990 | Substantially Equivalent |
| K902676 | MICROGUARD, ORTHOPEDIC PIN PROTECTORS | Sep 14, 1990 | Substantially Equivalent |
| K903650 | OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 | Sep 14, 1990 | Substantially Equivalent |
| K903664 | MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL | Sep 13, 1990 | Substantially Equivalent |
| K901967 | DENDIA WERK BURS AND CUTTING DISCS | Jul 13, 1990 | Substantially Equivalent |
| K901735 | ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 | Jun 20, 1990 | Substantially Equivalent |
| K902168 | ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS) | Jun 20, 1990 | Substantially Equivalent |
| K900033 | MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS | Feb 13, 1990 | Substantially Equivalent |
| K900210 | BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 | Feb 2, 1990 | Substantially Equivalent |