Akita Sumitomo Bakelite Co., Ltd.

FDA Regulatory Profile

Akita Sumitomo Bakelite Co., Ltd. appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0388-2017, Class II) was initiated on September 9, 2016.

Summary

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

Recent Recalls

NumberClassProductDate
Z-0388-2017Class IISB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product USeptember 9, 2016
Z-0389-2017Class IISB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. September 9, 2016