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FDA 510(k)

Duoblade

K-Number: K220996 · 2023-02-03

ApplicantCnc Technologies
Decision Date2023-02-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Duoblade is the device name listed in this FDA 510(k) record. The listed applicant is Cnc Technologies. It received FDA 510(k) clearance on 2023-02-03 under 510(k) number K220996. 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 Duoblade?

Duoblade is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Cnc Technologies. The 510(k) number is K220996.

When did Duoblade receive FDA 510(k) clearance?

Duoblade received FDA 510(k) clearance on 2023-02-03, under 510(k) number K220996.

Who is the listed applicant for Duoblade?

The FDA 510(k) record lists Cnc Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Duoblade?

The FDA product code for Duoblade is GEI.

Other records listing Cnc Technologies 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.

K252211Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)

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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