Iopsy Tray for Soft Tissue Biopsy
FDA 510(k) K771784 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK771784
Submission
- Device name
- Iopsy Tray for Soft Tissue Biopsy
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- September 23, 1977
- Decision date
- November 30, 1977
- 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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| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
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Questions and answers
When was Iopsy Tray for Soft Tissue Biopsy cleared by the FDA?
Iopsy Tray for Soft Tissue Biopsy (K771784) received a 510(k) decision of Substantially Equivalent on November 30, 1977, 68 days after the submission was received.
What is the product code of K771784?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.