Ultraclip II Wing and Ultraclip II Coil
FDA 510(k) K063238 · Inrad
510(k) numberK063238
Submission
- Device name
- Ultraclip II Wing and Ultraclip II Coil
- Applicant
- Inrad
Kentwood, MI, US - Received
- October 26, 2006
- Decision date
- January 30, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K093399 | Precisecore 10 MM Biopsy Device- 14GA X 5 CM Model 670514, 671014, 670518 671018, 670520KNW · Traditional | 11/19/2009SE |
| K093256 | Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018KNW · Traditional | 11/17/2009SE |
| K090611 | Revolution Full Core BiopsyKNW · Traditional | 06/04/2009SE |
| K042341 | Ultraclip II USNEU · Special | 09/20/2004SE |
| K041201 | Ultraclip II MRGDW · Special | 06/03/2004SE |
| K000612 | Accucore Single Action Core Biopsy DeviceKNW · Traditional | 04/24/2000SE |
Questions and answers
When was Ultraclip II Wing and Ultraclip II Coil cleared by the FDA?
Ultraclip II Wing and Ultraclip II Coil (K063238) received a 510(k) decision of Substantially Equivalent on January 30, 2007, 96 days after the submission was received.
What is the product code of K063238?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.