FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
K Number: K884709
·
Decision Sep 8, 1989
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
17
Applicant Total
14
Review Days
304
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Basic Information
- Device Name
- ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
- K Number
- K884709
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Primrose Medical, Inc.
- Date Received
- November 8, 1988
- Decision Date
- September 8, 1989
- Product Code
- ODD
- 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 |
|---|---|---|---|
| ODD | Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | FDA class 2 | Gastroenterology, Urology |
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Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter
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Other Clearances by Primrose Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884714 | BILIARY DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| 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 |
| 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 |