FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIBLE LIQUID LIGHT GUIDE
K Number: K834487
·
Decision Feb 21, 1984
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
25
Applicant Total
24
Review Days
70
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Basic Information
- Device Name
- FLEXIBLE LIQUID LIGHT GUIDE
- K Number
- K834487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Endo Lase, Inc.
- Date Received
- December 13, 1983
- Decision Date
- February 21, 1984
- Product Code
- FFS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FFS | Image, Illumination, Fiberoptic, For Endoscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFS), ordered by most recent decision date.
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
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SOVIS OPTIQUE'S ENDOSCOPIC CABLE
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MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
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FDA Class 2
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Other Clearances by Endo Lase, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853900 | ENDO-LASE CD40 FOR NEUROSURGERY | Jun 18, 1986 | Substantially Equivalent |
| K853878 | ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY | May 2, 1986 | Substantially Equivalent |
| K855093 | MEDILAS 2 ND:YAG LASER SURGERY SYSTEM | Feb 21, 1986 | Substantially Equivalent |
| K853903 | ENDO-LASE CD40 CO2 FOR GYNECOLOGY | Feb 21, 1986 | Substantially Equivalent |
| K853876 | ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY | Feb 21, 1986 | Substantially Equivalent |
| K853877 | ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY | Feb 19, 1986 | Substantially Equivalent |
| K853901 | ENDO-LASE CD 40 FOR DERMATOLOGY | Feb 19, 1986 | Substantially Equivalent |
| K853580 | MEDILAS 2 | Feb 13, 1986 | Substantially Equivalent |
| K860152 | MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY | Feb 5, 1986 | Substantially Equivalent |
| K853902 | ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY | Jan 9, 1986 | Substantially Equivalent |