FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BILIARY DIALATOR
K Number: K884714
·
Decision Sep 29, 1989
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
14
Review Days
325
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Basic Information
- Device Name
- BILIARY DIALATOR
- K Number
- K884714
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Primrose Medical, Inc.
- Date Received
- November 8, 1988
- Decision Date
- September 29, 1989
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
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Other Clearances by Primrose Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884715 | ACHELASIA BALLOON DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| K884713 | COLONIC BALLOON DIALATORS | Sep 29, 1989 | Substantially Equivalent |
| K884711 | URETHRAL AND URETERAL BALLOON DILATATORS | Sep 29, 1989 | Substantially Equivalent |
| K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | Sep 8, 1989 | Substantially Equivalent |
| K884712 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORS | 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 |