Kopans Hookwire Lesion Localization Needle
FDA 510(k) K900903 · Milex Products, Inc.
510(k) numberK900903
Submission
- Device name
- Kopans Hookwire Lesion Localization Needle
- Applicant
- Milex Products, Inc.
Chicago, IL, US - Received
- February 27, 1990
- Decision date
- May 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Bip USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001545 | Pipet CuretHHK · Special | 06/15/2000SE |
| K904774 | Inglat-O-BallHHW · Traditional | 12/07/1990SE |
| K904026 | Inflat-O-BallHHW · Traditional | 10/10/1990SE |
| K882628 | Endo C BrushHHT · Traditional | 07/25/1988SE |
| K862410 | Milex Kegel Perineal ExerciserHIR · Traditional | 07/31/1986SE |
| K861385 | Milex Bartholin Gland CatheterKNA · Traditional | 06/16/1986SE |
| K760264 | Curette, Proposed Tis-U-Trap, MetalHHK · Traditional | 10/06/1976SE |
Questions and answers
When was Kopans Hookwire Lesion Localization Needle cleared by the FDA?
Kopans Hookwire Lesion Localization Needle (K900903) received a 510(k) decision of Substantially Equivalent on May 3, 1990, 65 days after the submission was received.
What is the product code of K900903?
The FDA product code is GDF – Guide, Needle, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.