FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY
K Number: K933767
·
Decision May 26, 1994
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
21
Applicant Total
8
Review Days
301
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
- FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY
- K Number
- K933767
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mahe-Medizintechnik
- Date Received
- July 29, 1993
- Decision Date
- May 26, 1994
- 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
OWENS BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ROTO FIT BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
TISCHLER BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by Mahe-Medizintechnik
| K Number | Device Name | ||
|---|---|---|---|
| K942821 | MAHE INSTRUMENTS | Nov 2, 1994 | Substantially Equivalent |
| K942819 | TROCAR WITH SHIELD | Aug 23, 1994 | Substantially Equivalent |
| K933768 | COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES | Jun 27, 1994 | Substantially Equivalent |
| K933770 | FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE | Mar 23, 1994 | Substantially Equivalent |
| K935442 | MAHE INSTRUMENTS | Mar 14, 1994 | Substantially Equivalent |
| K933772 | PUNCH SURGICAL | Feb 1, 1994 | Substantially Equivalent |
| K925624 | MICROSURGICAL INSTRUMENTS | Jul 22, 1993 | Substantially Equivalent |