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FDA 510(k)

LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)

K-Number: K953559 · 1996-05-16

ApplicantSeidel Medizin GmbH
Decision Date1996-05-16
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Seidel Medizin GmbH. It received FDA 510(k) clearance on 1996-05-16 under 510(k) number K953559. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)?

LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-05-16. The listed applicant is Seidel Medizin GmbH. The 510(k) number is K953559.

When did LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) receive FDA 510(k) clearance?

LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) received FDA 510(k) clearance on 1996-05-16, under 510(k) number K953559.

Who is the listed applicant for LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)?

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

What is the FDA product code for LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)?

The FDA product code for LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) is BTO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Seidel Medizin GmbH 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.

K872486LARKEL DEVICE W/ATTACHMENTS A-H

Related Devices (Code: BTO)

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.

K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)Vitaltec CorporationK2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mmVitaltec CorporationK233713Pilling Tracheostomy TubesTeleflex MedicalK192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mmVenner Medical (Singapore) Pte, Ltd.K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeSmiths Medical Ads, Inc.K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)Primed Halberstadt Medizintechnik GmbH

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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