FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFEED DISP. PLASTIC CATHETER
K Number: K771212
·
Decision Sep 12, 1977
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
63
Applicant Total
31
Review Days
69
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
- SAFEED DISP. PLASTIC CATHETER
- K Number
- K771212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Terumo America, Inc.
- Date Received
- July 5, 1977
- Decision Date
- September 12, 1977
- Product Code
- KNY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNY), ordered by most recent decision date.
Bi-Flex Evo
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Vesair Cystoscopic Sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BI-FLEX URETERAL ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WIJAY EZ-VOID EXTERNAL CATHETER VALVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUARDIAN URETHRAL SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUARDIAN URETHRAL SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Terumo America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K811523 | PLASMA FLEX | Sep 9, 1981 | Substantially Equivalent |
| K802970 | TERUMO HOLLOW FIBER OXYGENATOR | Jan 22, 1981 | Substantially Equivalent |
| K802441 | CLIRANS TH10 HOLLOW FIBER DIALYZER | Dec 18, 1980 | Substantially Equivalent |
| K802122 | CLIRANS TH13 HOLLOW FIBER DIALYZER | Dec 18, 1980 | Substantially Equivalent |
| K801192 | CLIRANS TE10 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K801193 | CLIRANS TE15 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K801194 | CLIRANS TE07 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K791411 | COAXIAL DUAL FLOW CATHETER | Nov 13, 1979 | Substantially Equivalent |
| K791173 | SURFLO INJECTION PLUG | Jul 30, 1979 | Substantially Equivalent |
| K790105 | TERUMO IMUGARD | May 24, 1979 | Substantially Equivalent |