Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DESCRIBE PFD Patch

K-Number: K172689 · 2017-11-29

ApplicantMerz North America, Inc.
Decision Date2017-11-29
Product CodePKO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DESCRIBE PFD Patch is the device name listed in this FDA 510(k) record. The listed applicant is Merz North America, Inc.. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172689. The device is classified under product code PKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DESCRIBE PFD Patch?

DESCRIBE PFD Patch is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Merz North America, Inc.. The 510(k) number is K172689.

When did DESCRIBE PFD Patch receive FDA 510(k) clearance?

DESCRIBE PFD Patch received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172689.

Who is the listed applicant for DESCRIBE PFD Patch?

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

What is the FDA product code for DESCRIBE PFD Patch?

The FDA product code for DESCRIBE PFD Patch is PKO.

Related Clinical Trials

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.

NCT05773066A Study of Belotero® Intense Lidocaine for Lip AugmentationCOMPLETEDNCT07614997Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and NeckRECRUITING

Other records listing Merz North America, 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.

PMA P250016Implant, dermal, for aesthetic usePMA P050052Implant, dermal, for aesthetic usePMA P050037Implant, dermal, for aesthetic usePMA P040047AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USEPMA P250020Implant, dermal, for aesthetic usePMA P090016Implant, dermal, for aesthetic use

View all 7 devices →

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.

↑