Decision Date2016-03-04
Product CodeLFL
DecisionSubstantially Equivalent
Device Summary
HARMONIC HOOK is a medical device manufactured by Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2016-03-04 under approval number K151136. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HARMONIC HOOK?
HARMONIC HOOK is a medical device that received FDA 510(k) clearance on 2016-03-04. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K151136.
When was HARMONIC HOOK approved by the FDA?
HARMONIC HOOK received FDA 510(k) clearance on 2016-03-04, under approval number K151136.
What company makes HARMONIC HOOK?
HARMONIC HOOK is manufactured by Ethicon Endo-Surgery, LLC.
What is the FDA product code for HARMONIC HOOK?
The FDA product code for HARMONIC HOOK is LFL.
Other Devices by Ethicon Endo-Surgery, LLC
K160554Enseal X1 Large Jaw Tissue Sealer
K160128Endopath Electrosurgery Probe Plus II
K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm
K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length
K163523ECHELON CIRCULAR Powered Stapler
K163548ENSEAL X1 Large Jaw Tissue Sealer
View all 33 devices →
Related Devices (Code: LFL)
Official Source
View on FDA Database →
Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.