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)

RESTORELLE Y CONTOUR

K-Number: K123914 · 2013-03-05

ApplicantColoplast A/S
Decision Date2013-03-05
Product CodeOTO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESTORELLE Y CONTOUR is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2013-03-05 under 510(k) number K123914. The device is classified under product code OTO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTORELLE Y CONTOUR?

RESTORELLE Y CONTOUR is a medical device that received FDA 510(k) clearance on 2013-03-05. The listed applicant is Coloplast A/S. The 510(k) number is K123914.

When did RESTORELLE Y CONTOUR receive FDA 510(k) clearance?

RESTORELLE Y CONTOUR received FDA 510(k) clearance on 2013-03-05, under 510(k) number K123914.

Who is the listed applicant for RESTORELLE Y CONTOUR?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESTORELLE Y CONTOUR?

The FDA product code for RESTORELLE Y CONTOUR is OTO.

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 Coloplast A/S 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.

K262045Luja SoftK221874Altis Single Incision Sling SystemK220420Saffron Fixation SystemK191536Biatain Silicone AgK181811ReTrace Ureteral Access SheathK173527Digitex Delivery Device

View all 66 devices →

Related Devices (Code: OTO)

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.

K171271Polyform Synthetic MeshBoston Scientific CorporationK132061RESTORELLE M, RESTORELLE XLColoplast Corp.K123028VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESHCaldera Medical, Inc.K123337VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CMCaldera MedicalK122794UPSYLON Y MESHBoston Scientific CorpK122968NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015Coloplast Corp.

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.

↑