FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTEQUE VAGINAL DILATOR
K Number: K003380
·
Decision Jan 29, 2001
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
8
Applicant Total
10
Review Days
90
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Basic Information
- Device Name
- BIOTEQUE VAGINAL DILATOR
- K Number
- K003380
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.3900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bioteque America, Inc.
- Date Received
- October 31, 2000
- Decision Date
- January 29, 2001
- Product Code
- HDX
- 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 |
|---|---|---|---|
| HDX | Dilator, Vaginal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDX), ordered by most recent decision date.
Intimate Rose Vaginal Dilators
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Hope&Her Vaginal Dilators
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FDA Class 2
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Hope&Her Vaginal Dilators
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FDA Class 2
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Intimate Rose Vaginal Dilators
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Milli Vaginal Dilator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Milli Vaginal Dilator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Bioteque America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041094 | HSG CATHETER SET | Jun 17, 2004 | Substantially Equivalent |
| K020628 | CURELLE, PREFERRED CURELLE, CUTEQ 2.5 | May 24, 2002 | Substantially Equivalent |
| K013289 | BIOTEQUE VAGINAL PESSARIES | Dec 27, 2001 | Substantially Equivalent |
| K920633 | PESSARY FLEXIBLE SILICONE NICHOLS | Nov 8, 1995 | Substantially Equivalent |
| K920747 | PESSARY FLEXIBLE SILICONE DONUT RING | Aug 29, 1994 | Substantially Equivalent |
| K933628 | CYTOLOGY BRUSH | Mar 11, 1994 | Substantially Equivalent |
| K933521 | SPECULUM | Mar 7, 1994 | Substantially Equivalent |
| K920187 | FLEXIBLE SILICONE GELIHORN | Oct 23, 1992 | Substantially Equivalent |
| K920177 | VERSA-VIAL | Jul 13, 1992 | Substantially Equivalent |