FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP
K Number: K852357
·
Decision Jul 5, 1985
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
21
Applicant Total
5
Review Days
32
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
- GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP
- K Number
- K852357
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Gyneco, Inc.
- Date Received
- June 3, 1985
- Decision Date
- July 5, 1985
- Product Code
- HFB
- 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 |
|---|---|---|---|
| HFB | Forceps, Biopsy, Gynecological | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFB), ordered by most recent decision date.
SPIRABRUSH CX BIOPSY INSTRUMENT
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
CIT BIOPSY PUNCHES
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
OWENS BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ROTO FIT BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by Gyneco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861409 | SYNCARE TEMPORARY CARDIAC PACING WIRE | May 5, 1986 | Substantially Equivalent |
| K853216 | MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 | Apr 2, 1986 | Substantially Equivalent |
| K843941 | ENDOCYTE | Feb 25, 1985 | Substantially Equivalent |
| K841275 | FINE NEEDLE ASPIRATION DEVICE | Aug 17, 1984 | Substantially Equivalent |