FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS
K Number: K911163
·
Decision Jun 3, 1991
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
22
Applicant Total
19
Review Days
80
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Basic Information
- Device Name
- IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS
- K Number
- K911163
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Imagyn Medical, Inc.
- Date Received
- March 15, 1991
- Decision Date
- June 3, 1991
- Product Code
- FWF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FWF | Camera, Television, Endoscopic, Without Audio | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
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VES 1501-M
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Other Clearances by Imagyn Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972426 | MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH | Sep 23, 1997 | Substantially Equivalent |
| K970750 | MICROSPAN INSEMINATION SYSTEM | May 5, 1997 | Substantially Equivalent |
| K971255 | IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER | Apr 21, 1997 | Substantially Equivalent |
| K965055 | IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES | Mar 6, 1997 | Substantially Equivalent |
| K963580 | IMAGYN FALLOPOSCOPY SYSTEM | Jan 31, 1997 | Substantially Equivalent |
| K961688 | MICROSPAN HYSTEROSCOPE | Oct 15, 1996 | Substantially Equivalent |
| K961506 | MICROSPAN HYSTEROSCOPE SHEATH | Jul 3, 1996 | Substantially Equivalent |
| K952032 | IMAGYN HYSTEROSCOPE SHEATHS | Oct 31, 1995 | Substantially Equivalent |
| K951996 | IMAGYN ENDOSCOPE | Sep 1, 1995 | Substantially Equivalent |
| K951974 | IMAGYN ENDOSCOPE SHEATH | Aug 28, 1995 | Substantially Equivalent |