Medline Grounding Pad
FDA 510(k) K011515 · Medline Industries, Inc.
510(k) numberK011515
Submission
- Device name
- Medline Grounding Pad
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- May 17, 2001
- Decision date
- July 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JOS – Electrode, Electrosurgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Medline Grounding Pad cleared by the FDA?
Medline Grounding Pad (K011515) received a 510(k) decision of Substantially Equivalent on July 13, 2001, 57 days after the submission was received.
What is the product code of K011515?
The FDA product code is JOS – Electrode, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.