FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE PLASTIC VAGINAL SPECULA
K Number: K926536
·
Decision Feb 25, 1994
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
71
Applicant Total
33
Review Days
422
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
- DISPOSABLE PLASTIC VAGINAL SPECULA
- K Number
- K926536
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thomasville Medical Assoc.
- Date Received
- December 30, 1992
- Decision Date
- February 25, 1994
- Product Code
- HIB
- 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 |
|---|---|---|---|
| HIB | Speculum, Vaginal, Nonmetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIB), ordered by most recent decision date.
JFord Speculum Sleeve
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BRELLA-SPEC(TM) VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IOB DISPOSABLE SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CLEARSPEC SINGLE USE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPECULUM, VAGINAL, NONMETAL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KOLPLUX SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Thomasville Medical Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K926429 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Feb 28, 1994 | Substantially Equivalent |
| K926531 | HYSTERECTOMY FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926527 | ROTO FIT BIOPSY FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926535 | GOMCO CIRCUMCISION CLAMP | Feb 25, 1994 | Substantially Equivalent |
| K926533 | Z-CLAMP FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926540 | SOPHER AND BIERER OVUM FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926532 | ENDO CERVICAL CURETTE | Feb 25, 1994 | Substantially Equivalent |
| K930030 | SUCTION TUBES: HOUSE, BARON | Feb 25, 1994 | Substantially Equivalent |
| K926484 | CORSON MYOMA GRASPING FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926471 | MOGAN CIRCUMCISION CLAMP | Feb 25, 1994 | Substantially Equivalent |