FDA 510(k)

Sterile single use tip cleaner (WK800-S10 , WK800-S20)

Numéro K : K241022 · 2024-07-11

DemandeurWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd

Date de décision2024-07-11

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Sterile single use tip cleaner (WK800-S10 , WK800-S20) is the device name listed in this FDA 510(k) record. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2024-07-11 under 510(k) number K241022. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sterile single use tip cleaner (WK800-S10 , WK800-S20)?

Sterile single use tip cleaner (WK800-S10 , WK800-S20) is a medical device that received FDA 510(k) clearance on 2024-07-11. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. The 510(k) number is K241022.

When did Sterile single use tip cleaner (WK800-S10 , WK800-S20) receive FDA 510(k) clearance?

Sterile single use tip cleaner (WK800-S10 , WK800-S20) received FDA 510(k) clearance on 2024-07-11, under 510(k) number K241022.

Who is the listed applicant for Sterile single use tip cleaner (WK800-S10 , WK800-S20)?

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

What is the FDA product code for Sterile single use tip cleaner (WK800-S10 , WK800-S20)?

The FDA product code for Sterile single use tip cleaner (WK800-S10 , WK800-S20) is GEI.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd en tant que demandeur

K222828Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A K172578Equipment Pouch K172794Suction Irrigation Set K172038Trocar K172120Veress Needle

Dispositifs connexes (Code : GEI)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.