Ultraclip II US
FDA 510(k) K042341 · Inrad
510(k) numberK042341
Submission
- Device name
- Ultraclip II US
- Applicant
- Inrad
Kentwood, MI, US - Received
- August 30, 2004
- Decision date
- September 20, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from Molli Surgical, Inc.
| 510(k) | Device | Decision |
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| K243886 | ExpressCore Biopsy DeviceKNW · Traditional | 04/29/2025SE |
| K240429 | Trilogy Tissue MarkerNEU · Traditional | 11/07/2024SE |
| K183503 | EasyMark Tissue MarkerNEU · Traditional | 10/17/2019SE |
| K112945 | Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, With/Hilitier 18GAX10CM…KNW · Special | 11/03/2011SE |
| 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 |
| K063238 | Ultraclip II Wing and Ultraclip II CoilNEU · Traditional | 01/30/2007SE |
| 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 US cleared by the FDA?
Ultraclip II US (K042341) received a 510(k) decision of Substantially Equivalent on September 20, 2004, 21 days after the submission was received.
What is the product code of K042341?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.