FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECULITE
K Number: K963391
·
Decision Dec 12, 1997
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
7
Review Days
471
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Basic Information
- Device Name
- SPECULITE
- K Number
- K963391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trylon Corp.
- Date Received
- August 28, 1996
- Decision Date
- December 12, 1997
- Product Code
- MPU
- 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 |
|---|---|---|---|
| MPU | Source, Chemiluminescent Light | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MPU), ordered by most recent decision date.
View allOther Clearances by Trylon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K033033 | VIZILITE-BLUE ORAL EXAM KIT | Nov 22, 2004 | Substantially Equivalent |
| K011488 | SPIRABRUSH CX BIOPSY INSTRUMENT | Feb 22, 2002 | Substantially Equivalent |
| K012070 | ORALLITE COMPREHENSIVE EXAM TRAY | Nov 27, 2001 | Substantially Equivalent |
| K003995 | SPECULITE/ORALLITE | Mar 16, 2001 | Substantially Equivalent |
| K955790 | PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY | Mar 21, 1996 | Substantially Equivalent |
| K953364 | SPECULITE | Dec 8, 1995 | Substantially Equivalent |