FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
K Number: K980247
·
Decision Mar 17, 1998
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
19
Applicant Total
5
Review Days
53
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
- GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
- K Number
- K980247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gynex Corp.
- Date Received
- January 23, 1998
- Decision Date
- March 17, 1998
- Product Code
- HDC
- 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 |
|---|---|---|---|
| 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