FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES
K Number: K003695
·
Decision Feb 14, 2001
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
669
Applicant Total
8
Review Days
76
Basic Information
- Device Name
- MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES
- K Number
- K003695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MICRO-MEDICAL DEVICES, INC.
- Date Received
- November 30, 2000
- Decision Date
- February 14, 2001
- 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 MICRO-MEDICAL DEVICES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K983882 | MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 | Mar 15, 1999 | Substantially Equivalent |
| K963675 | THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE | Jan 27, 1997 | Substantially Equivalent |
| K951482 | ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE) | Sep 14, 1995 | Substantially Equivalent |
| K951894 | ACCESS EXPANSION SYSTEM | Jun 15, 1995 | Unknown |
| K945656 | THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE | Mar 28, 1995 | Substantially Equivalent |
| K940141 | LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH | May 19, 1994 | Substantially Equivalent |
| K936213 | ARTHROSCOPES AND ACCESSORIES | May 18, 1994 | Substantially Equivalent |