FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIBLE CHOLEDOCHOSCOPE
K Number: K901010
·
Decision May 22, 1990
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
42
Applicant Total
14
Review Days
78
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Basic Information
- Device Name
- FLEXIBLE CHOLEDOCHOSCOPE
- K Number
- K901010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Intramed Laboratories, Inc.
- Date Received
- March 5, 1990
- Decision Date
- May 22, 1990
- Product Code
- FBN
- 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 |
|---|---|---|---|
| FBN | Choledochoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Intramed Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953258 | TITANIUM HEMOSTATIC CLIP | Jan 5, 1996 | Substantially Equivalent |
| K942457 | GRAFT THROMBECTOMY INSTRUMENTS | Feb 7, 1995 | Substantially Equivalent |
| K931792 | ARTHROSCOPE | Jun 13, 1994 | Substantially Equivalent |
| K925283 | VALVULOTOME | Feb 10, 1994 | Substantially Equivalent |
| K934696 | ANGIOSCOPE | Jan 18, 1994 | Substantially Equivalent |
| K922114 | ENDOSCOPIC RETRIEVAL BASKET | Aug 3, 1992 | Substantially Equivalent |
| K914385 | OPTICAL VALVULOTOME | Mar 2, 1992 | Substantially Equivalent |
| K904465 | FLEXIBLE ARTHROSCOPE | Dec 20, 1990 | Substantially Equivalent |
| K903528 | LAPAROSCOPE | Sep 4, 1990 | Substantially Equivalent |
| K902444 | CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP | Aug 30, 1990 | Substantially Equivalent |