FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT
K Number: K954562
·
Decision Dec 22, 1995
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
72
Applicant Total
1
Review Days
81
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
- GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT
- K Number
- K954562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gynetech, Inc.
- Date Received
- October 2, 1995
- Decision Date
- December 22, 1995
- Product Code
- HHT
- 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 |
|---|---|---|---|
| HHT | Spatula, Cervical, Cytological | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHT), ordered by most recent decision date.
exCellerator Cervical Collection Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Kolplast Cervical Sample Collection Kit
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DISPOSABLE CERVICAL BRUSH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HISTOBRUSH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PAPCONE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology