FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BURBANK TENACULUM, MODEL 09-0011-01
K Number: K030078
·
Decision Jan 24, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
19
Applicant Total
9
Review Days
15
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
- BURBANK TENACULUM, MODEL 09-0011-01
- K Number
- K030078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Control Systems, Inc.
- Date Received
- January 9, 2003
- Decision Date
- January 24, 2003
- Product Code
- HDC
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HDC | Tenaculum, Uterine | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDC), ordered by most recent decision date.
Carevix Suction Cervical Stabilizer
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ASPIVIX v1.1 Cervical Suction Tenaculum
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Bioceptive Suction Cervical Retractor
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JARIT HULKA UTERINE TENACULUM FORCEPS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GYN DISPOSABLES TENACULUM 356T
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FEMTEN CERVICAL TENACULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Vascular Control Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060573 | BURBANK TENACULUM | Apr 21, 2006 | Substantially Equivalent |
| K052209 | VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 | Sep 6, 2005 | Substantially Equivalent |
| K032125 | CSTAT, MODELS 09-0014-01 AND 09-0014-02 | Feb 9, 2004 | Substantially Equivalent |
| K031812 | TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 | Dec 12, 2003 | Substantially Equivalent |
| K031358 | TRANSVAGINAL DOPPLER PROBE | May 9, 2003 | Substantially Equivalent |
| K023154 | VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 | Dec 20, 2002 | Substantially Equivalent |
| K023024 | TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 | Sep 26, 2002 | Substantially Equivalent |
| K011863 | VCS-A SERIES CLAMP | Feb 15, 2002 | Substantially Equivalent |