Arthrex Fingershield Finger Guard, Model AR-7199-XX
FDA 510(k) K052387 · Arthrex, Inc.
510(k) numberK052387
Submission
- Device name
- Arthrex Fingershield Finger Guard, Model AR-7199-XX
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- August 31, 2005
- Decision date
- November 29, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZB – Finger Cot
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
Other 510(k)s with product code LZB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992539 | PercuguardLZB · Traditional | Digit-Pro | 02/18/2000SE |
| K980827 | Latex Finger Cot, Powder-Free, with Protein LabelingLZB · Traditional | Tucker & Associates | 05/04/1998SE |
| K912042 | Bethel Plus Multiple NamesLZB · Traditional | Bethel Latex Products, Inc. | 07/02/1991SE |
| K903073 | Latex Finger CotsLZB · Traditional | Dongkuk Trading Co., Ltd. | 09/12/1990SE |
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Questions and answers
When was Arthrex Fingershield Finger Guard, Model AR-7199-XX cleared by the FDA?
Arthrex Fingershield Finger Guard, Model AR-7199-XX (K052387) received a 510(k) decision of Substantially Equivalent on November 29, 2005, 90 days after the submission was received.
What is the product code of K052387?
The FDA product code is LZB – Finger Cot, a Class I (low risk) device regulated under 21 CFR 880.6250.