Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11

K-Number: K200841 · 2020-05-11

ApplicantEthicon Endo-Surgery, LLC
Decision Date2020-05-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 is a medical device manufactured by Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2020-05-11 under approval number K200841. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11?

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 is a medical device that received FDA 510(k) clearance on 2020-05-11. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K200841.

When was Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 approved by the FDA?

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 received FDA 510(k) clearance on 2020-05-11, under approval number K200841.

What company makes Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11?

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 is manufactured by Ethicon Endo-Surgery, LLC.

What is the FDA product code for Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11?

The FDA product code for Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 is GEI.

Related Clinical Trials

NCT06608485 A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures RECRUITING

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 K151136HARMONIC HOOK 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

View all 33 devices →

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑