Percuguard
FDA 510(k) K992539 · Digit-Pro
510(k) numberK992539
Submission
- Device name
- Percuguard
- Applicant
- Digit-Pro
Houston, TX, US - Received
- July 30, 1999
- Decision date
- February 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K052387 | Arthrex Fingershield Finger Guard, Model AR-7199-XXLZB · Traditional | Arthrex, Inc. | 11/29/2005SE |
| 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 |
Questions and answers
When was Percuguard cleared by the FDA?
Percuguard (K992539) received a 510(k) decision of Substantially Equivalent on February 18, 2000, 203 days after the submission was received.
What is the product code of K992539?
The FDA product code is LZB – Finger Cot, a Class I (low risk) device regulated under 21 CFR 880.6250.