FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZEISS OPMI L STEREO-LAPAROSCOPE
K Number: K931478
·
Decision Sep 28, 1994
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
44
Review Days
553
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Basic Information
- Device Name
- ZEISS OPMI L STEREO-LAPAROSCOPE
- K Number
- K931478
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Carl Zeiss, Inc.
- Date Received
- March 24, 1993
- Decision Date
- September 28, 1994
- Product Code
- HET
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Carl Zeiss, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013402 | VISULAS 532S | Nov 14, 2001 | Substantially Equivalent |
| K003885 | VISULAS YAG II | Feb 22, 2001 | Substantially Equivalent |
| K993357 | IOLMASTER | Mar 20, 2000 | Substantially Equivalent |
| K983868 | OPMI TWINER SURGICAL MICROSCOPE | Jan 29, 1999 | Substantially Equivalent |
| K965139 | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM | Apr 23, 1997 | Substantially Equivalent |
| K961380 | CPC PROBE | Mar 17, 1997 | Substantially Equivalent |
| K961171 | HUMPHREY OCT SCANNER | Jun 21, 1996 | Substantially Equivalent |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | Nov 24, 1995 | Substantially Equivalent |
| K952894 | VISULINK 900 ARGON | Aug 14, 1995 | Substantially Equivalent |
| K950985 | ZEISS ENDOLIVE STERO ENDOSCOPE | Mar 29, 1995 | Substantially Equivalent |