FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT
K Number: K943989
·
Decision Sep 12, 1994
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
7
Review Days
27
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
- LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT
- K Number
- K943989
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2700
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gabris Surgical Corp.
- Date Received
- August 16, 1994
- Decision Date
- September 12, 1994
- Product Code
- HFO
- 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 |
|---|---|---|---|
| HFO | Recorder, Pressure, Intrauterine | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFO), ordered by most recent decision date.
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UC-2000 UTERINE CATHERIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FETAL MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Gabris Surgical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K954774 | SHIELDED TROCAR (OBTURATOR) | Jun 7, 1996 | Substantially Equivalent |
| K953548 | LAPAROSCOPIC SURGICAL INSTRUMENT | Sep 19, 1995 | Substantially Equivalent |
| K944640 | LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT | Oct 11, 1994 | Substantially Equivalent |
| K944104 | GABRIS LAPAROSCOPIC SURGICAL KITS | Sep 13, 1994 | Substantially Equivalent |
| K944103 | LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT | Sep 12, 1994 | Substantially Equivalent |
| K930716 | LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION | Jul 23, 1993 | Substantially Equivalent |