FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BOWEN CANNULA
K Number: K863150
·
Decision Sep 5, 1986
Classifications
1
FEI Numbers
378
Registration Numbers
378
Same Product Code
35
Applicant Total
14
Review Days
21
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
- BOWEN CANNULA
- K Number
- K863150
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Bowen & Company, Inc.
- Date Received
- August 15, 1986
- Decision Date
- September 5, 1986
- Product Code
- GEA
- 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 |
|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEA), ordered by most recent decision date.
MRI SAFE INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GENICON TROCAR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CONMED TROGARD ELECTRONIC TROCAR SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ORIGIN SECONDARY CANNULA AND TROCAR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Bowen & Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896898 | BOWEN ELECTRODE SKIN PREPATORY CLEANSER | Apr 4, 1990 | Substantially Equivalent |
| K896538 | DISPOSABLE 45 DEGREE SHAVER | Dec 6, 1989 | Substantially Equivalent |
| K873766 | STERNAL POWER AWL | Nov 14, 1988 | Substantially Equivalent |
| K872098 | CREMEEN ALVEOLAR BONE CALIPER | Jul 31, 1987 | Substantially Equivalent |
| K871325 | BOWEN REUSEABLE/DISPOSABLE ELECTRODE | Jun 8, 1987 | Substantially Equivalent |
| K870882 | 45 DEGREE SHAVER | Mar 23, 1987 | Substantially Equivalent |
| K870881 | LOOSE BODY GRASPERS | Mar 23, 1987 | Substantially Equivalent |
| K863146 | BOWEN SUTURE PASSER | Sep 5, 1986 | Substantially Equivalent |
| K863148 | BOWEN KNOT PASSER | Sep 5, 1986 | Substantially Equivalent |
| K863149 | BOWEN PROBE | Sep 5, 1986 | Substantially Equivalent |