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FDA 510(k)

Ritleng®+ and Ritleng®+ PVP

K-Number: K201892 · 2021-03-11

ApplicantFci (France Chirurgie Instrumentation) Sas
Decision Date2021-03-11
Product CodeOKS
DecisionSubstantially Equivalent

Device Summary

Ritleng®+ and Ritleng®+ PVP is the device name listed in this FDA 510(k) record. The listed applicant is Fci (France Chirurgie Instrumentation) Sas. It received FDA 510(k) clearance on 2021-03-11 under 510(k) number K201892. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ritleng®+ and Ritleng®+ PVP?

Ritleng®+ and Ritleng®+ PVP is a medical device that received FDA 510(k) clearance on 2021-03-11. The listed applicant is Fci (France Chirurgie Instrumentation) Sas. The 510(k) number is K201892.

When did Ritleng®+ and Ritleng®+ PVP receive FDA 510(k) clearance?

Ritleng®+ and Ritleng®+ PVP received FDA 510(k) clearance on 2021-03-11, under 510(k) number K201892.

Who is the listed applicant for Ritleng®+ and Ritleng®+ PVP?

The FDA 510(k) record lists Fci (France Chirurgie Instrumentation) Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ritleng®+ and Ritleng®+ PVP?

The FDA product code for Ritleng®+ and Ritleng®+ PVP is OKS.

Other records listing Fci (France Chirurgie Instrumentation) Sas 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.

K212741EZYPORK203569Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid ImplantsK201606LacriJet®

Related Devices (Code: OKS)

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.

K201606LacriJet®Fci (France Chirurgie Instrumentation) SasK170247Lacriflow CLKaneka Pharma America, LLCK161373NunchakuFci (France Chirurgie Instrumentation)K160710Oasis Lacrimal Intubation SetAnodyne

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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