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FDA 510(k)

Exofin Precision Pen

K-Number: K212246 · 2021-09-09

ApplicantChemence Medical, Inc.
Decision Date2021-09-09
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Exofin Precision Pen is the device name listed in this FDA 510(k) record. The listed applicant is Chemence Medical, Inc.. It received FDA 510(k) clearance on 2021-09-09 under 510(k) number K212246. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exofin Precision Pen?

Exofin Precision Pen is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Chemence Medical, Inc.. The 510(k) number is K212246.

When did Exofin Precision Pen receive FDA 510(k) clearance?

Exofin Precision Pen received FDA 510(k) clearance on 2021-09-09, under 510(k) number K212246.

Who is the listed applicant for Exofin Precision Pen?

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

What is the FDA product code for Exofin Precision Pen?

The FDA product code for Exofin Precision Pen is MPN.

Other records listing Chemence Medical, 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.

K200264Exofin High Viscosity Topical Skin AdhesiveK191461Exofin Fusion Skin Closure SystemK171442Exofin Fusion Skin Closure SystemK162352derma+flex QS High Viscosity Tissue Adhesive

Related Devices (Code: MPN)

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.

K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc.K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant MedicalK234114CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)Okapi Medical, LLC Dba Resivant MedicalK233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical , Ltd.K230981Meriglu Topical Skin AdhesiveM/s. Meril Endo Surgery Private Limited.K200264Exofin High Viscosity Topical Skin AdhesiveChemence Medical, 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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