Manan Accura Needle
FDA 510(k) K974741 · Medical Device Technologies, Inc.
510(k) numberK974741
Submission
- Device name
- Manan Accura Needle
- Applicant
- Medical Device Technologies, Inc.
Gainsville, FL, US - Received
- December 19, 1997
- Decision date
- January 8, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 Manan Accura Needle cleared by the FDA?
Manan Accura Needle (K974741) received a 510(k) decision of Substantially Equivalent on January 8, 1998, 20 days after the submission was received.
What is the product code of K974741?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.