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FDA 510(k)

OBS Electrosurgical Generator (Model: OBS-350A)

K-Number: K162034 · 2017-01-30

ApplicantBaisheng Medical Co., Ltd.
Decision Date2017-01-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OBS Electrosurgical Generator (Model: OBS-350A) is the device name listed in this FDA 510(k) record. The listed applicant is Baisheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-01-30 under 510(k) 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. The listed applicant is Baisheng Medical Co., Ltd.. The 510(k) number is K162034.

When did OBS Electrosurgical Generator (Model: OBS-350A) receive FDA 510(k) clearance?

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

Who is the listed applicant for OBS Electrosurgical Generator (Model: OBS-350A)?

The FDA 510(k) record lists Baisheng Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Baisheng Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250841Electrotherapy ElectrodesK251235Electrosurgical PadsK233615Electrosurgical 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 1K221815Electrosurgical 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)

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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