FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
K Number: K020628
·
Decision May 24, 2002
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
41
Applicant Total
10
Review Days
87
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Basic Information
- Device Name
- CURELLE, PREFERRED CURELLE, CUTEQ 2.5
- K Number
- K020628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1175
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bioteque America, Inc.
- Date Received
- February 26, 2002
- Decision Date
- May 24, 2002
- Product Code
- HHK
- 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 |
|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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DISPOSABLE ENDOMETRIAL SUCTION CURETTE
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Other Clearances by Bioteque America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041094 | HSG CATHETER SET | Jun 17, 2004 | Substantially Equivalent |
| K013289 | BIOTEQUE VAGINAL PESSARIES | Dec 27, 2001 | Substantially Equivalent |
| K003380 | BIOTEQUE VAGINAL DILATOR | Jan 29, 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 |