FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
K Number: K971255
·
Decision Apr 21, 1997
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
19
Review Days
17
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Basic Information
- Device Name
- IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
- K Number
- K971255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imagyn Medical, Inc.
- Date Received
- April 4, 1997
- Decision Date
- April 21, 1997
- 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 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 |
| 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 |
| K953201 | IMAGYN UROSCOPE | Aug 2, 1995 | Substantially Equivalent |