Incisive Surgical Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
5
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0078-2019Class IIINSORB SUBCUTICULAR SKIN STAPLER, REF 2030August 29, 2018
Z-1545-2015Class IIInsorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a sMarch 19, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K120373INSORB ABSORBALBE STAPLEMarch 16, 2012
K090159INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIESFebruary 6, 2009
K061784INSORB ABSORBABLE STAPLE, MODEL 1020July 26, 2006
K033602INSORB ABSORBABLE STAPLE, MODEL SP-B20December 16, 2003
K024117INSORB ABSORBABLE STAPLES, MODEL SP-B20April 22, 2003