FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FRAZIER SUCTION TUBE
K Number: K864382
·
Decision Jan 14, 1987
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
48
Applicant Total
15
Review Days
70
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FRAZIER SUCTION TUBE
- K Number
- K864382
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4350
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Luxtec Corp.
- Date Received
- November 5, 1986
- Decision Date
- January 14, 1987
- 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
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
JED-LIGHT FIBEROPTIC LIGHT SOURCE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
COLD LIGHT SOURCE LOS 150
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE
FDA 510(k)
FDA Class 1
·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 Luxtec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K973193 | LUXSCOPE | Nov 21, 1997 | Substantially Equivalent |
| K970642 | TENOSCOPE | May 21, 1997 | Substantially Equivalent |
| K970562 | TENOSNARE | May 14, 1997 | Substantially Equivalent |
| K950960 | REDDY ILLUMINATOR | Sep 8, 1995 | Substantially Equivalent |
| K895248 | IMS5000 ILLUMINATED LOUPES | Sep 15, 1989 | Substantially Equivalent |
| K890716 | LUXTEC ACO SERIES 4000 LIGHT SOURCE | Apr 26, 1989 | Substantially Equivalent |
| K864387 | LUXTEC FIBEROPTIC CABLES | May 22, 1987 | Substantially Equivalent |
| K864383 | LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS | Jan 14, 1987 | Substantially Equivalent |
| K864385 | LUXTEC LIGHT SOURCES | Jan 13, 1987 | Substantially Equivalent |
| K864865 | SPECULUM, VAGINAL, METAL FIBEROPTIC | Jan 9, 1987 | Substantially Equivalent |