FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLONIC BALLOON DIALATORS
K Number: K884713
·
Decision Sep 29, 1989
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
4
Applicant Total
14
Review Days
325
Basic Information
- Device Name
- COLONIC BALLOON DIALATORS
- K Number
- K884713
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5450
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- PRIMROSE MEDICAL, INC.
- Date Received
- November 8, 1988
- Decision Date
- September 29, 1989
- Product Code
- FFP
- 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 |
|---|---|---|---|
| FFP | Dilator, Rectal | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFP), ordered by most recent decision date.
ANOKRYO
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Other Clearances by PRIMROSE MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K884715 | ACHELASIA BALLOON DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| K884711 | URETHRAL AND URETERAL BALLOON DILATATORS | Sep 29, 1989 | Substantially Equivalent |
| K884714 | BILIARY DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| K884712 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORS | Sep 8, 1989 | Substantially Equivalent |
| K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | Sep 8, 1989 | Substantially Equivalent |
| K883420 | LANCET, BLOOD | Aug 26, 1988 | Substantially Equivalent |
| K881976 | CATHETER, INTRAVASCULAR | Aug 4, 1988 | Substantially Equivalent |
| K881977 | PRESSURE INFUSOR | Jul 29, 1988 | Substantially Equivalent |
| K881975 | SET, INTRAVASCULAR | Jul 29, 1988 | Substantially Equivalent |
| K881978 | ENTERAL FEEDING TUBES | Jul 13, 1988 | Substantially Equivalent |