Breast Stabilizer
FDA 510(k) K925874 · Bip USA, Inc.
510(k) numberK925874
Submission
- Device name
- Breast Stabilizer
- Applicant
- Bip USA, Inc.
Niagara Falls, NY, US - Received
- November 19, 1992
- Decision date
- March 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K023173 | Andrews Introducer, Model ASI01MDM · Traditional | Andrews Surgical Innovations, Ltd. | 12/18/2002SE |
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| K013040 | Light Saber Introducer NeedleMDM · Traditional | Minrad, Inc. | 12/07/2001SE |
| K010184 | Chess Hand Surgery SystemMDM · Traditional | Canica Design, Inc. | 06/22/2001SE |
| K990062 | SaphliftMDM · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 03/30/1999SE |
| K981579 | Endopouch Pro Specimen Retrieval BagMDM · Traditional | ETHICON, Inc. | 07/09/1998SE |
| K943968 | TunnelerMDM · Traditional | Denver Biomedicals, Inc. | 03/01/1995SE |
More from Denver Biomedicals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K024089 | Vacuflash Biopsy SystemKNW · Traditional | 03/11/2003SE |
| K934371 | Bip Multi ModificationKNW · Traditional | 04/28/1994SE |
| K934370 | Bip Biopsy Needle ModificationFCG · Traditional | 03/07/1994SE |
| K935457 | Localization Wire or Marker - SurgicalGDF · Traditional | 02/17/1994SE |
| K925870 | SpacerMJG · Traditional | 05/19/1993SE |
| K925875 | Horizontal Needle Guide AttachmentGDF · Traditional | 04/06/1993SE |
Questions and answers
When was Breast Stabilizer cleared by the FDA?
Breast Stabilizer (K925874) received a 510(k) decision of Substantially Equivalent on March 16, 1993, 117 days after the submission was received.
What is the product code of K925874?
The FDA product code is MDM – Instrument, Manual, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.