CAZ — Anesthesia Conduction Kit Class II
FDA product code CAZ covers "Anesthesia Conduction Kit", a Class II medical device regulated under 21 CFR 868.5140. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CAZ
- Device Class
- Class II
- Regulation Number
- 868.5140
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K222341 | arrow international | Arrow 0.2 Micron Flat Filter, GVS | February 13, 2023 |
| K210983 | becton, dickinson and | BD Epilor Syringe | May 19, 2022 |
| K201356 | jiangsu caina medical co | Plastic LOR Syringe | February 12, 2021 |
| K202699 | pajunk gmbh medizintechnologie | E-Cath STIM acc. Tsui | December 29, 2020 |
| K190345 | pajunk gmbh medizintechnologie | VPC | May 16, 2019 |
| K161075 | teleflexmedical | Arrow Epidural Catheter Kit | October 4, 2016 |
| K153652 | teleflex | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | June 21, 2016 |
| K143581 | teleflexmedical | Arrow Epidural Catheter Kit | June 26, 2015 |
| K122690 | arrow international | ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE | December 21, 2012 |
| K110053 | smiths medical asd | CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRIN | September 14, 2012 |
| K122027 | arrow international | ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER | August 28, 2012 |
| K121525 | smiths medical asd | PERIFUSE CATHETER | August 2, 2012 |
| K121403 | teleflex | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET | June 20, 2012 |
| K103658 | teleflex | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER | May 16, 2012 |
| K113662 | imd | FENESTRATED NERVE BLOCK NEEDLE | April 20, 2012 |
| K113188 | pajunk gmbh medizintechnologie | SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG | March 1, 2012 |
| K113059 | b.braun medical | CONTIPLEX FX | January 24, 2012 |
| K111355 | life-tech | ECHOBRIGHT | September 16, 2011 |
| K102007 | life-tech | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, | December 22, 2010 |
| K093662 | life-tech | ECHOBRIGHT | June 24, 2010 |