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FDA 510(k)

RESTORELLE L

K-Number: K122440 · 2012-11-19

ApplicantColoplast Corp.
Decision Date2012-11-19
Product CodeOTO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESTORELLE L is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2012-11-19 under 510(k) number K122440. 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 L?

RESTORELLE L is a medical device that received FDA 510(k) clearance on 2012-11-19. The listed applicant is Coloplast Corp.. The 510(k) number is K122440.

When did RESTORELLE L receive FDA 510(k) clearance?

RESTORELLE L received FDA 510(k) clearance on 2012-11-19, under 510(k) number K122440.

Who is the listed applicant for RESTORELLE L?

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

What is the FDA product code for RESTORELLE L?

The FDA product code for RESTORELLE L is OTO.

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Other records listing Coloplast Corp. as applicant

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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.K123914RESTORELLE Y CONTOURColoplast A/SK123337VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CMCaldera MedicalK122794UPSYLON Y MESHBoston Scientific 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.

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