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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 a medical device manufactured by Fci (France Chirurgie Instrumentation) Sas. It received FDA 510(k) clearance on 2021-03-11 under approval 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. It is manufactured by Fci (France Chirurgie Instrumentation) Sas. The 510(k) number is K201892.

When was Ritleng®+ and Ritleng®+ PVP approved by the FDA?

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

What company makes Ritleng®+ and Ritleng®+ PVP?

Ritleng®+ and Ritleng®+ PVP is manufactured by Fci (France Chirurgie Instrumentation) Sas.

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

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

Other Devices by Fci (France Chirurgie Instrumentation) Sas

K201606LacriJet® K203569Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants K212741EZYPOR

Related Devices (Code: OKS)

K161373NunchakuFci (France Chirurgie Instrumentation) K160710Oasis Lacrimal Intubation SetAnodyne K170247Lacriflow CLKaneka Pharma America, LLC K201606LacriJet®Fci (France Chirurgie Instrumentation) Sas

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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