FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLPOSCOPES AND ACCESSORIES
K Number: K940094
·
Decision Apr 25, 1995
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
55
Applicant Total
10
Review Days
473
Basic Information
- Device Name
- COLPOSCOPES AND ACCESSORIES
- K Number
- K940094
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1630
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- LEISEGANG MEDICAL, INC.
- Date Received
- January 7, 1994
- Decision Date
- April 25, 1995
- Product Code
- HEX
- 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 |
|---|---|---|---|
| HEX | Colposcope (And Colpomicroscope) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by LEISEGANG MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K990043 | SMOOTHLASE ALEXANDRITE LASER SYSTEM | Feb 11, 1999 | Substantially Equivalent |
| K924134 | LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS | Jul 2, 1993 | Substantially Equivalent |
| K920217 | MAX-E-VAC | Jul 23, 1992 | Substantially Equivalent |
| K914201 | LM- LAP 10 HIGH FLOW INSUFFLATOR | Jan 9, 1992 | Substantially Equivalent |
| K912789 | LM-100/200LOW FLOW INSUFFLATOR | Sep 20, 1991 | Substantially Equivalent |
| K913135 | LM-300TWIN | Sep 18, 1991 | Substantially Equivalent |
| K911212 | LM-150HT LIGHT SOURCE | May 23, 1991 | Substantially Equivalent |
| K902313 | LM-1Z ZOOM SCOPE | Sep 4, 1990 | Substantially Equivalent |
| K854767 | LM 1000 | Jan 24, 1986 | Substantially Equivalent |