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FDA 510(k)

ENDO TWINN

K-Number: K042870 · 2005-01-11

ApplicantEndo Twinn B.V.
Decision Date2005-01-11
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDO TWINN is the device name listed in this FDA 510(k) record. The listed applicant is Endo Twinn B.V.. It received FDA 510(k) clearance on 2005-01-11 under 510(k) number K042870. The device is classified under product code EKM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO TWINN?

ENDO TWINN is a medical device that received FDA 510(k) clearance on 2005-01-11. The listed applicant is Endo Twinn B.V.. The 510(k) number is K042870.

When did ENDO TWINN receive FDA 510(k) clearance?

ENDO TWINN received FDA 510(k) clearance on 2005-01-11, under 510(k) number K042870.

Who is the listed applicant for ENDO TWINN?

The FDA 510(k) record lists Endo Twinn B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDO TWINN?

The FDA product code for ENDO TWINN is EKM.

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 Endo Twinn B.V. 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.

K070246DOWN PAK

Related Devices (Code: EKM)

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.

K073369EI DOWNPAK BARRIER SLEEVESHu-Friedy Mfg. Co., Inc.K070246DOWN PAKEndo Twinn B.V.K051573TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)Dr. Howard Martin, P.A.K023819FIBERFILL SGPPentron Clinical TechnologiesK971641ANTIBACTERIAL GUTTA PERCHADr. Howard Martin, P.A.K970134THERMAPREP PLUS OVENTulsa Dental Products, Ltd.

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.

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