FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONCEPT C-VAC
K Number: K842710
·
Decision Oct 31, 1984
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
83
Review Days
111
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
- CONCEPT C-VAC
- K Number
- K842710
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Concept, Inc.
- Date Received
- July 12, 1984
- Decision Date
- October 31, 1984
- Product Code
- GCY
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCY), ordered by most recent decision date.
REDYROB-CLOSED WOUND DRAINAGE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PENROSE DRAIN MODELS 6001 - 6007
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MACRO SUCTION TUBE MODEL NO 10061
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PRESSURE IRRIGATING SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Concept, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912640 | CONCEPT ENDOSTEAL FIXATION DEVICE | May 1, 1992 | Substantially Equivalent |
| K912957 | CONCEPT MICROMILL | Oct 4, 1991 | Substantially Equivalent |
| K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM | Jun 5, 1990 | Substantially Equivalent for Some Indications |
| K894929 | STAPLE FIXATION SYSTEM | Aug 30, 1989 | Substantially Equivalent |
| K892376 | INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) | Aug 1, 1989 | Substantially Equivalent |
| K891109 | PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE | May 8, 1989 | Substantially Equivalent |
| K881954 | CONCEPT POWER SYSTEM | Nov 9, 1988 | Substantially Equivalent |
| K884255 | CONCEPT CCT-5200, THERMAL THERAPY SYSTEM | Nov 8, 1988 | Substantially Equivalent |
| K882121 | C-FLO SUCTION TUBE | Jun 20, 1988 | Substantially Equivalent |
| K880414 | TENDON HARVESTER | Mar 25, 1988 | Substantially Equivalent |