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FDA 510(k)

BiPad Hand Activated, Disposable Bipolar Electrocautery Cords

K-Number: K201833 · 2020-07-31

ApplicantBipad Surgical, Inc.
Decision Date2020-07-31
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BiPad Hand Activated, Disposable Bipolar Electrocautery Cords is the device name listed in this FDA 510(k) record. The listed applicant is Bipad Surgical, Inc.. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K201833. 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 BiPad Hand Activated, Disposable Bipolar Electrocautery Cords?

BiPad Hand Activated, Disposable Bipolar Electrocautery Cords is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Bipad Surgical, Inc.. The 510(k) number is K201833.

When did BiPad Hand Activated, Disposable Bipolar Electrocautery Cords receive FDA 510(k) clearance?

BiPad Hand Activated, Disposable Bipolar Electrocautery Cords received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201833.

Who is the listed applicant for BiPad Hand Activated, Disposable Bipolar Electrocautery Cords?

The FDA 510(k) record lists Bipad Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BiPad Hand Activated, Disposable Bipolar Electrocautery Cords?

The FDA product code for BiPad Hand Activated, Disposable Bipolar Electrocautery Cords is GEI.

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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