FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIOSCOPE
K Number: K894459
·
Decision Mar 7, 1990
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
40
Applicant Total
14
Review Days
232
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
- ANGIOSCOPE
- K Number
- K894459
- 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
- July 18, 1989
- Decision Date
- March 7, 1990
- Product Code
- LYK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| LYK | Angioscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYK), ordered by most recent decision date.
Vena MicroAngioscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Vena MicroAngioscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KSEA FIBERSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |