FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HSG CATHETER SET
K Number: K041094
·
Decision Jun 17, 2004
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
10
Review Days
51
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Basic Information
- Device Name
- HSG CATHETER SET
- K Number
- K041094
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bioteque America, Inc.
- Date Received
- April 27, 2004
- Decision Date
- June 17, 2004
- Product Code
- LKF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Bioteque America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020628 | CURELLE, PREFERRED CURELLE, CUTEQ 2.5 | May 24, 2002 | 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 |