Global Medical Products Brest Lesion Localization Needle with Stiffened Wire
FDA 510(k) K950311 · Global Medical Products, Ltd.
510(k) numberK950311
Submission
- Device name
- Global Medical Products Brest Lesion Localization Needle with Stiffened Wire
- Applicant
- Global Medical Products, Ltd.
Woodbury, CT, US - Received
- January 16, 1995
- Decision date
- May 26, 1995
- 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 |
| 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 |
| K935457 | Localization Wire or Marker - SurgicalGDF · Traditional | Bip USA, Inc. | 02/17/1994SE |
| 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 |
|---|---|---|
| K970916 | H.V. Pulse Lavage (L31 Series)FQH · Traditional | 06/20/1997SE |
| K962821 | Epidural Anesthesia Kit and Combined Spinal Epidural Anesthesia KitCAZ · Traditional | 11/13/1996SESK |
| K961444 | Global Medical Combined Spinal Epidural Kit (Gma 1827 and Gma 1725)BSP · Traditional | 08/01/1996SE |
| K951448 | Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single…DRC · Traditional | 03/27/1996SE |
| K951421 | Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene NeedlesFCG · Traditional | 11/16/1995SE |
Questions and answers
When was Global Medical Products Brest Lesion Localization Needle with Stiffened Wire cleared by the FDA?
Global Medical Products Brest Lesion Localization Needle with Stiffened Wire (K950311) received a 510(k) decision of Substantially Equivalent on May 26, 1995, 130 days after the submission was received.
What is the product code of K950311?
The FDA product code is GDF – Guide, Needle, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.