510(k) K250011

Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) by Turbett Surgical — Product Code FRG

K250011 is an FDA 510(k) premarket notification submitted by Turbett Surgical for the device "Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)". The FDA issued a decision of Substantially Equivalent on April 4, 2025. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Turbett Surgical has at least 3 other 510(k) clearances on record.