FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CURELLE
K Number: K915491
·
Decision Nov 4, 1992
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
41
Applicant Total
11
Review Days
334
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Basic Information
- Device Name
- CURELLE
- K Number
- K915491
- 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 Corp.
- Date Received
- December 6, 1991
- Decision Date
- November 4, 1992
- 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
Other 510(k) clearances with the same product code (HHK), ordered by most recent decision date.
Uterine Aspiration Set
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RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
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CrossGlide ETS Plus
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CrossBay Endometrial Tissue Sampler (ETS)
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DISPOSABLE ENDOMETRIAL SUCTION CURETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
THE PANPAC SUCTION CURETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Bioteque Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K150932 | Sheath Introducer | Jul 22, 2016 | Substantially Equivalent |
| K102633 | BIOTEQ ANGIOGRAPHIC CATHETER | Sep 9, 2011 | Substantially Equivalent |
| K033862 | BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK | Feb 14, 2005 | Substantially Equivalent |
| K033210 | BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET | Dec 30, 2004 | Substantially Equivalent |
| K032292 | BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX | Mar 22, 2004 | Substantially Equivalent |
| K013634 | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK | Jul 9, 2002 | Unknown |
| K012526 | BIOTEQUE SCALP VEIN SET | Sep 14, 2001 | Substantially Equivalent |
| K002449 | BIOTEQ I.V. (INTRAVENOUS) SET | Dec 22, 2000 | Substantially Equivalent |
| K992930 | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET | Feb 9, 2000 | Substantially Equivalent |
| K993118 | BIOTEQUE A.V. FISTULA NEEDLE SET | Dec 17, 1999 | Substantially Equivalent |