FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMAGYN ENDOSCOPE SHEATH
K Number: K951974
·
Decision Aug 28, 1995
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
19
Review Days
123
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Basic Information
- Device Name
- IMAGYN ENDOSCOPE SHEATH
- K Number
- K951974
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imagyn Medical, Inc.
- Date Received
- April 27, 1995
- Decision Date
- August 28, 1995
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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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 |
| K953201 | IMAGYN UROSCOPE | Aug 2, 1995 | Substantially Equivalent |