FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT
K Number: K926429
·
Decision Feb 28, 1994
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
10
Applicant Total
33
Review Days
432
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Basic Information
- Device Name
- VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT
- K Number
- K926429
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4520
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thomasville Medical Assoc.
- Date Received
- December 23, 1992
- Decision Date
- February 28, 1994
- Product Code
- HDF
- 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 |
|---|---|---|---|
| HDF | Speculum, Vaginal, Metal | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDF), ordered by most recent decision date.
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Other Clearances by Thomasville Medical Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K926536 | DISPOSABLE PLASTIC VAGINAL SPECULA | 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 |