FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECULUM, VAGINAL, METAL FIBEROPTIC
K Number: K864865
·
Decision Jan 9, 1987
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
1
Applicant Total
15
Review Days
29
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Basic Information
- Device Name
- SPECULUM, VAGINAL, METAL FIBEROPTIC
- K Number
- K864865
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4520
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Luxtec Corp.
- Date Received
- December 11, 1986
- Decision Date
- January 9, 1987
- Product Code
- HDG
- 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 |
|---|---|---|---|
| HDG | Speculum, Vaginal, Metal, Fiberoptic | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDG), ordered by most recent decision date.
View allOther 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 |
| K864382 | FRAZIER SUCTION TUBE | Jan 14, 1987 | Substantially Equivalent |
| K864385 | LUXTEC LIGHT SOURCES | Jan 13, 1987 | Substantially Equivalent |