Kopan's Target
FDA 510(k) K915417 · Medical Device Technologies, Inc.
510(k) numberK915417
Submission
- Device name
- Kopan's Target
- Applicant
- Medical Device Technologies, Inc.
Gainsville, FL, US - Received
- December 2, 1991
- Decision date
- January 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K102274 | Arvik Laparoscopic Aspiration InstrumentGAA · Traditional | Arvik Enterprises/ Mini Lap Technologies | 06/15/2011SE |
| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | Diametrics Medical, Inc. | 11/16/2001SE |
| K994151 | Percutx-Injection/Aspiration Needle Probes/DevicesGAA · Traditional | Ximed/Prosure/Injectx | 03/01/2000SE |
| K983200 | Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexGAA · Traditional | Ximed/Prosure/Injectx | 12/11/1998SE |
| K974741 | Manan Accura NeedleGAA · Traditional | Medical Device Technologies, Inc. | 01/08/1998SE |
| K962425 | Bonopty Coaxial Bone Biopsy System with Eccentric DRILL(10-1072,3,4)GAA · Traditional | Radi Medical Systems AB | 09/11/1996SE |
| K961959 | MD Tech Biopsy Set for Bone and Bone MarrowGAA · Traditional | Medical Device Technologies, Inc. | 07/19/1996SE |
| K945109 | Monoject Bone Marrow Biopsy TraysGAA · Traditional | Sherwood Medical Co. | 11/14/1994SE |
| K940025 | Manan Bone Marrow Harvest NeedlesGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K101832 | Biopince Ultra Full Core Biopsy InstrumentKNW · Traditional | 08/27/2010SE |
| K053518 | Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Special | 01/26/2006SE |
| K051421 | Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Traditional | 08/30/2005SE |
| K050873 | Canalizer Hydrophilic Guide WireDQX · Traditional | 05/26/2005SE |
| K043523 | Interv Brand Snarelok Bone Marrow Biopsy NeedleKNW · Traditional | 02/11/2005SE |
| K042464 | V-Core Full Core Breast Biopsy InstrumentKNW · Traditional | 09/30/2004SE |
| K040427 | Fibrex Catheter Patency DeviceFOZ · Traditional | 05/03/2004SE |
| K031442 | PBN GuidewiresDQX · Traditional | 08/13/2003SE |
| K021606 | En-Snare Endovascular Snare and CatheterMMX · Traditional | 05/31/2002SE |
| K011790 | Microcruiser Plus Introducer SetDYB · Traditional | 09/05/2001SE |
Questions and answers
When was Kopan's Target cleared by the FDA?
Kopan's Target (K915417) received a 510(k) decision of Substantially Equivalent on January 14, 1992, 43 days after the submission was received.
What is the product code of K915417?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.