FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUID COOLED BONE SAW BLADE, 6000 SERIES
K Number: K924953
·
Decision Jan 21, 1993
Classifications
1
FEI Numbers
304
Registration Numbers
304
Same Product Code
26
Applicant Total
38
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
- FLUID COOLED BONE SAW BLADE, 6000 SERIES
- K Number
- K924953
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boehringer Laboratories
- Date Received
- September 30, 1992
- Decision Date
- January 21, 1993
- Product Code
- GFA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GFA), ordered by most recent decision date.
GRAFT HARVESTING SAWBLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER SAGITTAL SAW ATTACHMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WRIGHT MEDICAL TECHNOLOGY SAWBLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL SAW BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RE-SHARPENABLE SAW BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Boehringer Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K234145 | ViSiGi 3D Gastric Sizing Tube | Jan 26, 2024 | Substantially Equivalent |
| K061788 | BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM | Jul 11, 2006 | Substantially Equivalent |
| K060277 | BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM | Mar 3, 2006 | Substantially Equivalent |
| K020538 | BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES | May 15, 2002 | Substantially Equivalent |
| K014187 | AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM | Feb 6, 2002 | Substantially Equivalent |
| K013976 | BOEHRINGER MRI SUCTION REGULATORY | Jan 8, 2002 | Substantially Equivalent |
| K955010 | AUTOVAC BP SYSTE, 2000 SERIES | Jun 20, 1996 | Substantially Equivalent |
| K945775 | BOEHRINGER AUTOVAC(R) 7900 SERIES | Oct 19, 1995 | Substantially Equivalent |
| K932093 | AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S | Jul 6, 1994 | Substantially Equivalent |
| K933232 | BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED | Mar 28, 1994 | Substantially Equivalent |