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FDA 510(k)

PICO

K-Number: K111170 · 2011-12-15

ApplicantSmith & Nephew, Inc.
Decision Date2011-12-15
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PICO is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2011-12-15 under 510(k) number K111170. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICO?

PICO is a medical device that received FDA 510(k) clearance on 2011-12-15. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K111170.

When did PICO receive FDA 510(k) clearance?

PICO received FDA 510(k) clearance on 2011-12-15, under 510(k) number K111170.

Who is the listed applicant for PICO?

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

What is the FDA product code for PICO?

The FDA product code for PICO is OMP.

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Related Devices (Code: OMP)

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.

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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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