Accu-Core Disposable Biopsy Needle
FDA 510(k) K801457 · Medline Industries, Inc.
510(k) numberK801457
Submission
- Device name
- Accu-Core Disposable Biopsy Needle
- Applicant
- Medline Industries, Inc.
Mchenry, IL, US - Received
- June 24, 1980
- Decision date
- July 14, 1980
- 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 Accu-Core Disposable Biopsy Needle cleared by the FDA?
Accu-Core Disposable Biopsy Needle (K801457) received a 510(k) decision of Substantially Equivalent on July 14, 1980, 20 days after the submission was received.
What is the product code of K801457?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.