Needle W/Stylet for Implantation
FDA 510(k) K854238 · Microvasive
510(k) numberK854238
Submission
- Device name
- Needle W/Stylet for Implantation
- Applicant
- Microvasive
Milford, MA, US - Received
- October 21, 1985
- Decision date
- November 13, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | Diametrics Medical, Inc. | 11/16/2001SE |
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| 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 |
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| K940025 | Manan Bone Marrow Harvest NeedlesGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K872771 | Low Profile GastrostomyKNT · Traditional | 10/09/1987SE |
| K870705 | Thermal CoagulatorKNS · Traditional | 04/17/1987SE |
| K861323 | Replacement Gastrostomy TubeKNT · Traditional | 12/16/1986SE |
| K861309 | Jejunal Feeding TubeKNT · Traditional | 12/16/1986SE |
| K860589 | Inflator/Deflator Piston SyringeKNT · Traditional | 04/07/1986SE |
| K860366 | Challenger Hot Biopsy ForcepsKNS · Traditional | 04/07/1986SE |
| K854063 | Microvasive Silicone SprayKCT · Traditional | 10/25/1985SE |
| K851652 | PapillotomeKNS · Traditional | 06/24/1985SE |
| K850393 | Flexible Fiberoptic Endoscope · Traditional | 06/04/1985SE |
| K844769 | Rigid Fiberopitc EndoscopeGCM · Traditional | 01/15/1985SE |
Questions and answers
When was Needle W/Stylet for Implantation cleared by the FDA?
Needle W/Stylet for Implantation (K854238) received a 510(k) decision of Substantially Equivalent on November 13, 1985, 23 days after the submission was received.
What is the product code of K854238?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.