Percuguide Lesion Marking
FDA 510(k) K920816 · E-Z-Em, Inc.
510(k) numberK920816
Submission
- Device name
- Percuguide Lesion Marking
- Applicant
- E-Z-Em, Inc.
Glens Falls, NY, US - Received
- February 6, 1992
- Decision date
- April 21, 1992
- 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 |
| 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 |
|---|---|---|
| K071378 | Modification to Empower Ct/Cta Injector System, Models 9800/9900 Product SeriesJAK · Special | 06/13/2007SE |
| K062449 | Empowermr Injector System, Model 9730IZQ · Abbreviated | 04/13/2007SE |
| K063029 | Empower Ct/Cta Injector System, Model 9800/9900JAK · Special | 11/02/2006SE |
| K053008 | E-Z-Em Endoscopic CO2 RegulatorFCX · Abbreviated | 12/27/2005SE |
| K041178 | Empower Transfer Set, (Cat. No. 7725)FPK · Traditional | 07/16/2004SE |
| K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825IZQ · Special | 06/19/2003SE |
| K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400FCX · Special | 04/16/2003SE |
| K013219 | PROTOCO2L Insufflator Model 6400FCX · Abbreviated | 02/19/2002SE |
| K011160 | E-Z Em Percupump 2001 CT InjectorJAK · Special | 05/16/2001SE |
| K974621 | Percupump II with EdaDSB · Traditional | 01/27/1998SE |
Questions and answers
When was Percuguide Lesion Marking cleared by the FDA?
Percuguide Lesion Marking (K920816) received a 510(k) decision of Substantially Equivalent on April 21, 1992, 75 days after the submission was received.
What is the product code of K920816?
The FDA product code is GDF – Guide, Needle, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.