FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
K Number: K052314
·
Decision Nov 9, 2005
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
71
Applicant Total
19
Review Days
76
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Basic Information
- Device Name
- DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
- K Number
- K052314
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dynarex Corp.
- Date Received
- August 25, 2005
- Decision Date
- November 9, 2005
- 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 |
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Other Clearances by Dynarex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | Dec 22, 2005 | Substantially Equivalent |
| K012816 | DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 | Oct 17, 2002 | Substantially Equivalent |
| K012957 | TOWEL DRAPE, MODELS 4409, 4410 | Mar 6, 2002 | Substantially Equivalent |
| K012917 | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | Nov 28, 2001 | Substantially Equivalent |
| K991695 | DYNAREX NON-WOVEN SPONGE | Jul 15, 1999 | Substantially Equivalent |
| K991694 | DYNAREX DRAIN SPONGE | Jul 15, 1999 | Substantially Equivalent |
| K983348 | DYNAREX TRACHEOSTOMY SPONGE | Dec 11, 1998 | Substantially Equivalent |
| K960388 | DYNAREX NON-WOVEN SPONGE | Apr 1, 1996 | Substantially Equivalent |
| K951660 | DYNAREX GAUZE SPONGE | May 9, 1995 | Substantially Equivalent |
| K933308 | DYNAREX GAUZE SPONGE OR PADS | Dec 22, 1993 | Substantially Equivalent |