Hypodermic Needle and Stylet
FDA 510(k) K854579 · Berkley and Co.
510(k) numberK854579
Submission
- Device name
- Hypodermic Needle and Stylet
- Applicant
- Berkley and Co.
Spirit Lake, IA, US - Received
- November 15, 1985
- Decision date
- December 17, 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 |
| 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 |
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Questions and answers
When was Hypodermic Needle and Stylet cleared by the FDA?
Hypodermic Needle and Stylet (K854579) received a 510(k) decision of Substantially Equivalent on December 17, 1985, 32 days after the submission was received.
What is the product code of K854579?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.