FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BERNSTEIN(TM) UTERINE MANIPULATOR
K Number: K932394
·
Decision Jan 26, 1995
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
11
Review Days
618
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Basic Information
- Device Name
- BERNSTEIN(TM) UTERINE MANIPULATOR
- K Number
- K932394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gm Engineering, Inc.
- Date Received
- May 18, 1993
- Decision Date
- January 26, 1995
- Product Code
- LKF
- 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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Gm Engineering, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953348 | ARTICULATING RETRACTOR TISSUE RETRACTORS | Sep 12, 1995 | Substantially Equivalent |
| K942626 | CONTINUOUS FLOW BIOPSY PROBE | May 30, 1995 | Substantially Equivalent |
| K941661 | GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT | Aug 23, 1994 | Substantially Equivalent |
| K942703 | GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULA | Aug 19, 1994 | Substantially Equivalent |
| K941662 | GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT | Jul 20, 1994 | Substantially Equivalent |
| K941660 | GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT | May 24, 1994 | Substantially Equivalent |
| K933962 | GM CONTINUOUS FLOW BIOPSY PROBE | Feb 25, 1994 | Substantially Equivalent |
| K930611 | TRUE FLOW(TM) VALVE | Dec 1, 1993 | Substantially Equivalent |
| K934035 | GM MONOPOLAR/FRAZIER SUCTION PROBE | Dec 1, 1993 | Substantially Equivalent |
| K931398 | GM SWIVEL VIDEO (TM) IRRIGATOR | Aug 30, 1993 | Substantially Equivalent |