FDA-Device2023-05-17Class II
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
New Wave Endo-Surgical, Corp.
Hazard
The plastic housing on the device may fracture
Sold states
US Nationwide distribution in the states of FL, MA, and GA.
Affected count
295 units
Manufactured in
6601 Lyons Rd Ste D8, N/A, Coconut Creek, FL, United States
Products
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1570-2023Don't want to check this manually?
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