Stingray Surgical Products, LLC

FDA Regulatory Profile

Stingray Surgical Products, LLC appears in FDA public data with 1 recall, 3 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2011-2012, Class II) was initiated on May 23, 2012. Its most recent 510(k) clearance was granted on May 10, 2013.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2011-2012Class IIBipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.May 23, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K123478STINGRAY BIPOLAR FORCEPSMay 10, 2013
K102752STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPSNovember 9, 2011
K083162STINGRAY ELECTROSURGICAL FORCEPSJanuary 12, 2009