FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TISCHLER BIOPSY FORCEPS
K Number: K891034
·
Decision Mar 17, 1989
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
21
Applicant Total
76
Review Days
17
Basic Information
- Device Name
- TISCHLER BIOPSY FORCEPS
- K Number
- K891034
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- ZINNANTI SURGICAL INSTRUMENTS, INC.
- Date Received
- February 28, 1989
- Decision Date
- March 17, 1989
- 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 ZINNANTI SURGICAL INSTRUMENTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K925501 | NYLON COATED SPECULA | Jun 13, 1997 | Substantially Equivalent |
| K941458 | UTERINE MANIPULATOR/INJECTOR WITH SPRING | Jan 25, 1995 | Substantially Equivalent |
| K941457 | UTERINE INJECTOR WITH SPRING | Jan 24, 1995 | Substantially Equivalent |
| K925560 | ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES | Aug 30, 1994 | Substantially Equivalent |
| K925960 | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Jun 7, 1994 | Substantially Equivalent |
| K925957 | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Jun 7, 1994 | Substantially Equivalent |
| K926021 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE | Apr 7, 1994 | Substantially Equivalent |
| K925958 | SCISSOR FOR LAPAROSCOPIC SURGERY GU USE | Mar 24, 1994 | Substantially Equivalent |
| K926181 | ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY | Dec 17, 1993 | Substantially Equivalent |
| K925959 | FORCEPS FOR LAPAROSCOPIC SURGERY GU USE | Nov 12, 1993 | Substantially Equivalent |