Microguide Lesion Marking System
FDA 510(k) K923120 · Angiodynamics, Div. E-Z-Em, Inc.
510(k) numberK923120
Submission
- Device name
- Microguide Lesion Marking System
- Applicant
- Angiodynamics, Div. E-Z-Em, Inc.
Glens Falls, NY, US - Received
- June 26, 1992
- Decision date
- September 1, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| 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 |
|---|---|---|
| K961763 | Pulse*Spray Infusion SystemQEY · Traditional | 07/17/1996SE |
| K951509 | Pulse*Spray Infusion SystemQEY · Traditional | 06/16/1995SE |
| K951602 | Pulse*Spray Infusion SystemKRA · Traditional | 06/14/1995SE |
| K950907 | Pulse*Spray Infusion SystemQEY · Traditional | 05/17/1995SE |
| K933846 | Angiography Syringe KitsDXT · Traditional | 12/13/1994SE |
Questions and answers
When was Microguide Lesion Marking System cleared by the FDA?
Microguide Lesion Marking System (K923120) received a 510(k) decision of Substantially Equivalent on September 1, 1992, 67 days after the submission was received.
What is the product code of K923120?
The FDA product code is GDF – Guide, Needle, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.