510(k) K954989

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES by Smith & Nephew Dyonics, Inc. — Product Code ERL

K954989 is an FDA 510(k) premarket notification submitted by Smith & Nephew Dyonics, Inc. for the device "DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES". The FDA issued a decision of Substantially Equivalent on November 27, 1995. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. Smith & Nephew Dyonics, Inc. has at least 10 other 510(k) clearances on record.