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FDA 510(k)

pioli IOL Delivery System

K-Number: K172228 · 2017-12-15

ApplicantAst Products, Inc.
Decision Date2017-12-15
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

pioli IOL Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Ast Products, Inc.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K172228. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the pioli IOL Delivery System?

pioli IOL Delivery System is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Ast Products, Inc.. The 510(k) number is K172228.

When did pioli IOL Delivery System receive FDA 510(k) clearance?

pioli IOL Delivery System received FDA 510(k) clearance on 2017-12-15, under 510(k) number K172228.

Who is the listed applicant for pioli IOL Delivery System?

The FDA 510(k) record lists Ast Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for pioli IOL Delivery System?

The FDA product code for pioli IOL Delivery System is MSS.

Other records listing Ast Products, Inc. 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.

K200057bioli lOL Delivery SystemK182965BL-Cart IOL Delivery Cartridge

Related Devices (Code: MSS)

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.

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AGK242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, IncorporatedK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.

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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