FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
K Number: K941662
·
Decision Jul 20, 1994
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
48
Applicant Total
11
Review Days
106
Basic Information
- Device Name
- GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
- K Number
- K941662
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4350
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- GM ENGINEERING, INC.
- Date Received
- April 5, 1994
- Decision Date
- July 20, 1994
- Product Code
- EQH
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EQH | Source, Carrier, Fiberoptic Light | FDA class 1 | Ear, Nose, Throat |
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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 |
| K932394 | BERNSTEIN(TM) UTERINE MANIPULATOR | Jan 26, 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 |
| 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 |
| K934035 | GM MONOPOLAR/FRAZIER SUCTION PROBE | Dec 1, 1993 | Substantially Equivalent |
| K930611 | TRUE FLOW(TM) VALVE | Dec 1, 1993 | Substantially Equivalent |
| K931398 | GM SWIVEL VIDEO (TM) IRRIGATOR | Aug 30, 1993 | Substantially Equivalent |