Ulticare Safety Insulin Syringe
FDA 510(k) K103011 · Ulti-Med Intl., Inc.
510(k) numberK103011
Submission
- Device name
- Ulticare Safety Insulin Syringe
- Applicant
- Ulti-Med Intl., Inc.
Minneapolis, MN, US - Received
- October 12, 2010
- Decision date
- February 2, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K914244 | Sterile Custom Surgical KitsKDD · Traditional | 02/24/1992SEKD |
| K914431 | Absorbent FiberNAB · Traditional | 12/04/1991SE |
| K912693 | Post Operative SpongeNAB · Traditional | 10/04/1991SE |
| K912692 | Conforming BandageNAB · Traditional | 10/04/1991SE |
| K904896 | Eye PadHMP · Traditional | 12/05/1990SE |
| K901465 | Absorbable Gauze DrapeKKX · Traditional | 06/12/1990SE |
Questions and answers
When was Ulticare Safety Insulin Syringe cleared by the FDA?
Ulticare Safety Insulin Syringe (K103011) received a 510(k) decision of Substantially Equivalent on February 2, 2011, 113 days after the submission was received.
What is the product code of K103011?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.