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HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC vs easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd.: FDAPulse comparison

HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC's review days of 268 is 1.0x easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd.'s 268 (90th percentile). HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC is dated 2026-09-17; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd. 2026-09-25.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC compare to easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd.?

FieldHARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLCeasyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd.
Record510(k) clearance510(k) clearance
510(k) numberK254196K254291
DeviceHARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges
ApplicantEthicon Endo-Surgery, LLCEzisurg Medical Co., Ltd.
Specialty / panelGeneral, Plastic SurgeryGeneral, Plastic Surgery
Product codeGEIGDW
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2025-12-232025-12-31
Decision date2026-09-172026-09-25
Review time (days)268268
Third-party reviewNoNo
Applicant locationGuaynabo, PR, USShanghai, CN
amount percentile90th90th
Predicate Speed & CAPA Advisory Opportunity Score55/10061/100
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Official records: HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC · easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd.

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