FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUCTION CATHETER TRAYS
K Number: K833059
·
Decision Dec 12, 1983
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
23
Applicant Total
16
Review Days
95
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Basic Information
- Device Name
- SUCTION CATHETER TRAYS
- K Number
- K833059
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Intermed, Inc.
- Date Received
- September 8, 1983
- Decision Date
- December 12, 1983
- Product Code
- GBZ
- 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 |
|---|---|---|---|
| GBZ | Catheter, Cholangiography | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBZ), ordered by most recent decision date.
PRE-VIEW CHOLANGIOGRAPHY CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOPATH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Intermed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K900857 | NON STERILE PARENTERAL SUPPLY KIT | May 22, 1990 | Unknown |
| K842166 | INTERMED, INS STERILE WATER/SALINE | Feb 12, 1985 | Substantially Equivalent |
| K833126 | DRESSING CHANGE TRAYS | Jan 27, 1984 | Substantially Equivalent |
| K833574 | PERCUTANEOUS SHEATH INTRODUCER TRAYS | Jan 11, 1984 | Substantially Equivalent |
| K833573 | CENTRAL VEIN CATH. TRAY CC-20-1420 | Jan 11, 1984 | Substantially Equivalent |
| K833139 | ACUTE HEMODIALYSIS TRAYS | Dec 22, 1983 | Substantially Equivalent |
| K821269 | TRACHEOSTOMY CARE TRAYS | May 27, 1982 | Substantially Equivalent |
| K791427 | CATHETERIZATION TRAYS FOLEY AND URETHRAL | Sep 7, 1979 | Substantially Equivalent |
| K791426 | PERITONEAL PAC | Aug 28, 1979 | Substantially Equivalent |
| K781748 | IRRIGATION TRAY | Dec 12, 1978 | Substantially Equivalent |