FDA 510(k)

OBS Electrosurgical Generator (Model: OBS-350A)

K-Number: K162034 · 2017-01-30

Decision Date2017-01-30

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OBS Electrosurgical Generator (Model: OBS-350A) is a medical device manufactured by Baisheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-01-30 under approval number K162034. 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 OBS Electrosurgical Generator (Model: OBS-350A)?

OBS Electrosurgical Generator (Model: OBS-350A) is a medical device that received FDA 510(k) clearance on 2017-01-30. It is manufactured by Baisheng Medical Co., Ltd.. The 510(k) number is K162034.

When was OBS Electrosurgical Generator (Model: OBS-350A) approved by the FDA?

OBS Electrosurgical Generator (Model: OBS-350A) received FDA 510(k) clearance on 2017-01-30, under approval number K162034.

What company makes OBS Electrosurgical Generator (Model: OBS-350A)?

OBS Electrosurgical Generator (Model: OBS-350A) is manufactured by Baisheng Medical Co., Ltd..

What is the FDA product code for OBS Electrosurgical Generator (Model: OBS-350A)?

The FDA product code for OBS Electrosurgical Generator (Model: OBS-350A) is GEI.

Related Clinical Trials

NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING

Other Devices by Baisheng Medical Co., Ltd.

K221815Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) K233615Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 K250841Electrotherapy Electrodes K251235Electrosurgical Pads

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.