Arachnophlebectomy Needle
FDA 510(k) K000932 · Advanced Medical Products, Inc.
510(k) numberK000932
Submission
- Device name
- Arachnophlebectomy Needle
- Applicant
- Advanced Medical Products, Inc.
Clarksville, MD, US - Received
- March 23, 2000
- Decision date
- May 17, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAH – Stylet, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Arachnophlebectomy Needle cleared by the FDA?
Arachnophlebectomy Needle (K000932) received a 510(k) decision of Substantially Equivalent on May 17, 2000, 55 days after the submission was received.
What is the product code of K000932?
The FDA product code is GAH – Stylet, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.