FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LS3000 CANNULA UTERINE SUCTION
K Number: K862476
·
Decision Jul 18, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
23
Applicant Total
5
Review Days
18
Basic Information
- Device Name
- LS3000 CANNULA UTERINE SUCTION
- K Number
- K862476
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5070
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- ENGINEERING, INC.
- Date Received
- June 30, 1986
- Decision Date
- July 18, 1986
- Product Code
- HHI
- 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 |
|---|---|---|---|
| HHI | System, Abortion, Vacuum | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHI), ordered by most recent decision date.
Berkeley VC-10 Vacuum Curettage System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BERKELEY V-10 VACUUM CURETTAGE SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CYTOPREP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CYTOSMEAR BRUSH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CANNULA, SUCTION UTERINE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by ENGINEERING, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K881521 | MODIFIED SERVO SYRINGE | May 31, 1988 | Substantially Equivalent |
| K862749 | LS9000 SUCTION BIOPSY NEEDLE | Sep 15, 1986 | Substantially Equivalent |
| K854359 | LM2000A SURGICAL SUCTION MONITOR | Mar 3, 1986 | Substantially Equivalent |
| K854844 | LS1000 SURGICAL ASPIRATOR II | Feb 12, 1986 | Substantially Equivalent for Some Indications |