Data / Medical devices / United States / New Wave Endo
New Wave Endo: FDA-registered device maker in Coconut Creek, FL, United States, 1 510(k) clearance
New Wave Endo is registered with the FDA (registration 3015209038) in Coconut Creek, FL, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 8, 2005. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015209038
- Address
- 6601 Lyons Road Unit D8, Coconut Creek, FL, United States, 33073
- Owner or operator
- New Wave Endo (10060773)
- Roles
- Manufacturer
- First device listed
- June 21, 2019
- Registered through
- 2026
- Brand names listed
- M-Close, MPS Acacia Nerve Block Needle, Nerve Block Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anesthesia Conduction Kit | CAZ | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 8, 2005 | K052946 | MPS ACACIA NERVE BLOCK NEEDLE | CAZ | Substantially Equivalent | Mps Acacia | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 8, 2020 | 92005 | Class II | Terminated | M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall | The plastic housing on the device may fracture | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Suturing, Disposable
- All makers of Anesthesia Conduction Kit
- All makers of Instrument, Ligature Passing And Knot Tying
Updated May 9, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.