FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AED ARTHROSCOPE
K Number: K991656
·
Decision Dec 2, 1999
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
8
Review Days
203
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Basic Information
- Device Name
- AED ARTHROSCOPE
- K Number
- K991656
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- National Advanced Endoscopy Devices, Inc.
- Date Received
- May 13, 1999
- Decision Date
- December 2, 1999
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by National Advanced Endoscopy Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K170285 | AED Sinuscope | Aug 1, 2017 | Substantially Equivalent |
| 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 |
| K993689 | AED CYSTOSCOPE | Dec 15, 1999 | Substantially Equivalent |
| K993688 | AED LAPAROSCOPE | Dec 6, 1999 | Substantially Equivalent |