FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ASPIRATING ENDO OCULAR PROBE
K Number: K914247
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
48
Applicant Total
28
Review Days
86
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Basic Information
- Device Name
- ASPIRATING ENDO OCULAR PROBE
- K Number
- K914247
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4350
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Technologies, Inc.
- Date Received
- September 23, 1991
- Decision Date
- December 18, 1991
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EQH), ordered by most recent decision date.
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT
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JED-LIGHT FIBEROPTIC LIGHT SOURCE
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COLD LIGHT SOURCE LOS 150
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·Ear, Nose, Throat
BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE
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·Ear, Nose, Throat
GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Surgical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941992 | CYSTOSCOPE | Nov 30, 1995 | Substantially Equivalent |
| K942029 | ARTHROSCOPE | Nov 8, 1995 | Substantially Equivalent |
| K946136 | INFINITECH LIGHTED INFUSION CANNULA | Oct 2, 1995 | Substantially Equivalent |
| K952566 | OSCILFLATOR | Aug 31, 1995 | Substantially Equivalent |
| K951918 | SURGICAL TECHNOLOGIES, INC. SYRINGE | Jul 20, 1995 | Substantially Equivalent |
| K950683 | ARTHROGRAM TRAY | May 6, 1995 | Substantially Equivalent |
| K946135 | INFINITECH ASPIRATING LASER PROBE | Apr 18, 1995 | Substantially Equivalent |
| K946181 | INFINITECH SOFT TIP FLUTE NEEDLE | Mar 14, 1995 | Substantially Equivalent |
| K942030 | BIOPSY SCISSORS | Jun 27, 1994 | Substantially Equivalent |
| K942482 | PRESSURE MONITORING EXTENSION | Jun 14, 1994 | Substantially Equivalent |