Andrews Introducer, Model ASI01
FDA 510(k) K023173 · Andrews Surgical Innovations, Ltd.
510(k) numberK023173
Submission
- Device name
- Andrews Introducer, Model ASI01
- Applicant
- Andrews Surgical Innovations, Ltd.
Co. Dublin, IE - Received
- September 23, 2002
- Decision date
- December 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K050575 | Futumeds No Patient Contact Safety Lancet with Pals SystemMDM · Traditional | Futumeds Sdn Bhd | 08/15/2005SE |
| K050957 | EutrocharMDM · Traditional | Special Devices, Inc. | 05/18/2005SE |
| 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 Andrews Introducer, Model ASI01 cleared by the FDA?
Andrews Introducer, Model ASI01 (K023173) received a 510(k) decision of Substantially Equivalent on December 18, 2002, 86 days after the submission was received.
What is the product code of K023173?
The FDA product code is MDM – Instrument, Manual, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.