FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROUND SILICONE DRAIN
K Number: K782028
·
Decision Dec 20, 1978
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
50
Review Days
15
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
- ROUND SILICONE DRAIN
- K Number
- K782028
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Davol, Inc.
- Date Received
- December 5, 1978
- Decision Date
- December 20, 1978
- 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 Davol, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | Jun 12, 2025 | Substantially Equivalent |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Apr 9, 2025 | Substantially Equivalent |
| K031213 | AQUASENS FLUID MONITORING SYSTEM | Apr 30, 2003 | Substantially Equivalent |
| K030307 | DAVOL ARTHROVENT OUTFLOW TUBING | Feb 13, 2003 | Substantially Equivalent |
| K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 | Jan 22, 2001 | Substantially Equivalent |
| K003790 | DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 | Dec 22, 2000 | Substantially Equivalent |
| K931899 | DAVOL ATS | Nov 15, 1994 | Substantially Equivalent |
| K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE | Jun 14, 1994 | Substantially Equivalent |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | Mar 25, 1994 | Substantially Equivalent |
| K935503 | DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET | Mar 7, 1994 | Substantially Equivalent |