Futumeds No Patient Contact Safety Lancet with Pals System
FDA 510(k) K050575 · Futumeds Sdn Bhd
510(k) numberK050575
Submission
- Device name
- Futumeds No Patient Contact Safety Lancet with Pals System
- Applicant
- Futumeds Sdn Bhd
Puchong, MY - Received
- March 7, 2005
- Decision date
- August 15, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code MDM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073664 | Frontline Medical Safetynet Guidewire IntroducerMDM · Traditional | Injectimed, Inc. | 08/08/2008SE |
| K050957 | EutrocharMDM · Traditional | Special Devices, Inc. | 05/18/2005SE |
| K023173 | Andrews Introducer, Model ASI01MDM · Traditional | Andrews Surgical Innovations, Ltd. | 12/18/2002SE |
| K022059 | Microvasive Pulmonary GuidewireMDM · Traditional | Boston Scientific Corp | 11/13/2002SE |
| K013040 | Light Saber Introducer NeedleMDM · Traditional | Minrad, Inc. | 12/07/2001SE |
| K010184 | Chess Hand Surgery SystemMDM · Traditional | Canica Design, Inc. | 06/22/2001SE |
| K990062 | SaphliftMDM · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 03/30/1999SE |
| K981579 | Endopouch Pro Specimen Retrieval BagMDM · Traditional | ETHICON, Inc. | 07/09/1998SE |
| K943968 | TunnelerMDM · Traditional | Denver Biomedicals, Inc. | 03/01/1995SE |
| K945430 | Dermavblade(Tm)MDM · Traditional | Hasting'S Biomedical Corp. | 11/28/1994SE |
Questions and answers
When was Futumeds No Patient Contact Safety Lancet with Pals System cleared by the FDA?
Futumeds No Patient Contact Safety Lancet with Pals System (K050575) received a 510(k) decision of Substantially Equivalent on August 15, 2005, 161 days after the submission was received.
What is the product code of K050575?
The FDA product code is MDM – Instrument, Manual, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.