Harmonic Ace Laparoscopic 5mm Diameter Shears 36cm Length + Adaptive Tissue Tec…

FDA 510(k)EUDAMED

U (US FDA 510(k))

510(k) K121550

Identifiers

510(k) Number: K121550 FDA 510(k)
FDA Product Code: LFL FDA 510(k)

Classification

Device Class: U FDA 510(k)
Advisory Committee: Unknown FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Harmonic Ace Laparoscopic 5mm Diameter Shears 36cm Length + Adaptive Tissue Tec… by Ethicon Endo-Surgery, LLC — U — MDR, FDA_510K — listed in FDA 510(k)…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	U	Active
FDA 510(k)	United States	FDA_510K	K121550	U	Active

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Manufacturer

Manufacturer: Ethicon Endo-Surgery, LLC

Sources (2)

FDA 510(k) K121550 24 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced May 19, 2026