FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GALILEO ARTHROSCOPES
K Number: K936280
·
Decision Jul 12, 1994
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
7
Review Days
284
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Basic Information
- Device Name
- GALILEO ARTHROSCOPES
- K Number
- K936280
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Galileo Electro-Optics Corp.
- Date Received
- October 1, 1993
- Decision Date
- July 12, 1994
- 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 Galileo Electro-Optics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K981928 | GALILEO DISPOSABLE ENDOSCOPES | Aug 6, 1998 | Substantially Equivalent |
| K962256 | GALILEO HYSTEROSCOPES AND LAPAROSCOPES | Dec 6, 1996 | Substantially Equivalent |
| K962116 | GALILEO ENDOSCOPES | Nov 27, 1996 | Substantially Equivalent |
| K934649 | GALILEO ENDOSCOPES | Oct 13, 1994 | Substantially Equivalent |
| K934707 | GALILEO ARTHROSCOPES | Oct 7, 1994 | Substantially Equivalent |
| K936279 | GALILEO ENDOSCOPES | May 16, 1994 | Substantially Equivalent |