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

FDA 510(k)

CleanSeal Advanced Bipolar Vessel Sealer Maryland

K-Number: K231732 · 2023-10-23

ApplicantConmed Corporation
Decision Date2023-10-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CleanSeal Advanced Bipolar Vessel Sealer Maryland is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2023-10-23 under 510(k) number K231732. 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 CleanSeal Advanced Bipolar Vessel Sealer Maryland?

CleanSeal Advanced Bipolar Vessel Sealer Maryland is a medical device that received FDA 510(k) clearance on 2023-10-23. The listed applicant is Conmed Corporation. The 510(k) number is K231732.

When did CleanSeal Advanced Bipolar Vessel Sealer Maryland receive FDA 510(k) clearance?

CleanSeal Advanced Bipolar Vessel Sealer Maryland received FDA 510(k) clearance on 2023-10-23, under 510(k) number K231732.

Who is the listed applicant for CleanSeal Advanced Bipolar Vessel Sealer Maryland?

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

What is the FDA product code for CleanSeal Advanced Bipolar Vessel Sealer Maryland?

The FDA product code for CleanSeal Advanced Bipolar Vessel Sealer Maryland is GEI.

Other records listing Conmed Corporation 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.

K261363Y-Knotless™ Flex AnchorsK253763Y-Knotless™ Flex AnchorsK252946BioBrace® Extra-Articular Ligament Augmentation KitK251530CONMED Argo Knotless® AnchorK250395BioBrace ® RC Delivery SystemK244025Argo Knotless GENESYS Anchor

View all 48 devices →

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

View on FDA Database →

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

↑