Localization Wire or Marker - Surgical
FDA 510(k) K935457 · Bip USA, Inc.
510(k) numberK935457
Submission
- Device name
- Localization Wire or Marker - Surgical
- Applicant
- Bip USA, Inc.
Niagara Falls, NY, US - Received
- November 12, 1993
- Decision date
- February 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GDF – Guide, Needle, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031173 | Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013GDF · Traditional | Needle Tech Products, Inc. | 07/23/2003SE |
| K950311 | Global Medical Products Brest Lesion Localization Needle with Stiffened WireGDF · Traditional | Global Medical Products, Ltd. | 05/26/1995SE |
| K950007 | Surgical Instrument GuideGDF · Traditional | United States Surgical, A Division of Tyco Healthc | 03/15/1995SE |
| K945124 | Breast Lesion Localization NeedleGDF · Traditional | Promex, Inc. | 11/22/1994SE |
| K944942 | Breast Lesion Localization NeedleGDF · Traditional | Promedical , Ltd. | 11/04/1994SE |
| K935538 | Bauer Temno Coaxial NeedleGDF · Traditional | Bauer Medical, Inc. | 02/22/1994SE |
| K923840 | Needle-GrabberGDF · Traditional | Guardian Angel Products, Inc. | 07/13/1993SE |
| K923835 | The Eleventh FingerGDF · Traditional | Guardian Angel Products, Inc. | 07/09/1993SE |
| K925875 | Horizontal Needle Guide AttachmentGDF · Traditional | Bip USA, Inc. | 04/06/1993SE |
| K924270 | Breast Lesion Localization NeedleGDF · Traditional | Core Medical, Inc. | 09/23/1992SE |
More from Core Medical, 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 |
| K925870 | SpacerMJG · Traditional | 05/19/1993SE |
| K925875 | Horizontal Needle Guide AttachmentGDF · Traditional | 04/06/1993SE |
| K925874 | Breast StabilizerMDM · Traditional | 03/16/1993SE |
Questions and answers
When was Localization Wire or Marker - Surgical cleared by the FDA?
Localization Wire or Marker - Surgical (K935457) received a 510(k) decision of Substantially Equivalent on February 17, 1994, 97 days after the submission was received.
What is the product code of K935457?
The FDA product code is GDF – Guide, Needle, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.