FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AED CYSTOSCOPE
K Number: K993689
·
Decision Dec 15, 1999
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
79
Applicant Total
7
Review Days
44
Basic Information
- Device Name
- AED CYSTOSCOPE
- K Number
- K993689
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- Date Received
- November 1, 1999
- Decision Date
- December 15, 1999
- Product Code
- FAJ
- 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 |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K141515 | AED HYSTEROSCOPE AND ACCESSORIES | Jan 7, 2015 | Substantially Equivalent |
| K102663 | AED RESECTOSCOPE | Dec 30, 2010 | Substantially Equivalent |
| K081553 | AED BIPOLAR FORCEPS, MODEL 13-1646 | Sep 29, 2008 | Substantially Equivalent |
| K081503 | AED MONOPOLAR LAP ACCESSORIES | Sep 25, 2008 | Substantially Equivalent |
| K993688 | AED LAPAROSCOPE | Dec 6, 1999 | Substantially Equivalent |
| K991656 | AED ARTHROSCOPE | Dec 2, 1999 | Substantially Equivalent |