Chiba Needle
FDA 510(k) K851957 · Wilson-Cook Medical, Inc.
510(k) numberK851957
Submission
- Device name
- Chiba Needle
- Applicant
- Wilson-Cook Medical, Inc.
Winston-Salem, NC, US - Received
- May 3, 1985
- Decision date
- May 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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Questions and answers
When was Chiba Needle cleared by the FDA?
Chiba Needle (K851957) received a 510(k) decision of Substantially Equivalent on May 17, 1985, 14 days after the submission was received.
What is the product code of K851957?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.