Neurolac Nerve Guide
FDA 510(k) K050573 · Polyganics B.V.,
510(k) numberK050573
Submission
- Device name
- Neurolac Nerve Guide
- Applicant
- Polyganics B.V.,
Groningen, NL - Received
- March 7, 2005
- Decision date
- May 4, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JXI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260245 | SILKBridgeJXI · Traditional | KLISBio S.r.l. | 04/09/2026SE |
| K253363 | NeuroSpan BridgeJXI · Traditional | Auxilium Biotechnologies, Inc. | 01/17/2026SE |
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)JXI · Traditional | Alafair Biosciences | 07/22/2025SE |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)JXI · Traditional | Alafair Biosciences | 07/17/2025SE |
| K243889 | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40…JXI · Traditional | Orthocell, Ltd. | 04/02/2025SE |
| K242113 | Nerve Wrap (07-DW-001-TAB)JXI · Traditional | Biocircuit Technologies, Inc. | 04/02/2025SE |
| K233322 | Mochida Nerve CuffJXI · Traditional | Mochida Pharmaceutical Co., Ltd. | 06/21/2024SE |
| K233533 | NerveTapeJXI · Traditional | Biocircuit Technologies, Inc. | 02/12/2024SE |
| K230794 | Rebuilder Nerve Guidance ConduitJXI · Traditional | Celestray Biotech Company, LLC., | 01/29/2024SE |
| K232029 | VersaWrap Nerve ProtectorJXI · Traditional | Alafair Biosciences, Inc. | 11/02/2023SE |
More from Alafair Biosciences, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141816 | HemoporeLYA · Traditional | 10/23/2014SE |
| K141423 | Nasopore-FdLYA · Special | 08/07/2014SE |
| K112267 | Neurolac(R) Nerve GuideJXI · Special | 10/20/2011SE |
| K070715 | Nasopore EarNHB · Traditional | 05/07/2007SE |
| K062540 | Nasopore Ear, Models ND04, ND05KCN · Traditional | 10/18/2006SE |
| K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZzLYA · Traditional | 11/21/2005SE |
| K042811 | Vivosorb Sheet, Model FS01FTL · Traditional | 11/08/2004SE |
| K032115 | Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03JXI · Traditional | 10/10/2003SE |
Questions and answers
When was Neurolac Nerve Guide cleared by the FDA?
Neurolac Nerve Guide (K050573) received a 510(k) decision of Substantially Equivalent on May 4, 2005, 58 days after the submission was received.
What is the product code of K050573?
The FDA product code is JXI – Cuff, Nerve, a Class II (moderate risk) device regulated under 21 CFR 882.5275.