Medline Retractable Safety Syringe
FDA 510(k) K101560 · Medline Industries, Inc.
510(k) numberK101560
Submission
- Device name
- Medline Retractable Safety Syringe
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- June 4, 2010
- Decision date
- March 25, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEG – Syringe, Antistick
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…MEG · Traditional | Jiangsu Kangbao Medical Equipment Co., Ltd. | 11/01/2022SE |
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Questions and answers
When was Medline Retractable Safety Syringe cleared by the FDA?
Medline Retractable Safety Syringe (K101560) received a 510(k) decision of Substantially Equivalent on March 25, 2011, 294 days after the submission was received.
What is the product code of K101560?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.