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)

Avance Tubing, Avance Y-Connector, Avance ViewPad

K-Number: K161797 · 2016-10-19

ApplicantMolnlycke Health Care Us, LLC
Decision Date2016-10-19
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Avance Tubing, Avance Y-Connector, Avance ViewPad is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K161797. 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 Avance Tubing, Avance Y-Connector, Avance ViewPad?

Avance Tubing, Avance Y-Connector, Avance ViewPad is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K161797.

When did Avance Tubing, Avance Y-Connector, Avance ViewPad receive FDA 510(k) clearance?

Avance Tubing, Avance Y-Connector, Avance ViewPad received FDA 510(k) clearance on 2016-10-19, under 510(k) number K161797.

Who is the listed applicant for Avance Tubing, Avance Y-Connector, Avance ViewPad?

The FDA 510(k) record lists Molnlycke Health Care Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avance Tubing, Avance Y-Connector, Avance ViewPad?

The FDA product code for Avance Tubing, Avance Y-Connector, Avance ViewPad is OMP.

Other records listing Molnlycke Health Care Us, LLC 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.

K232508Barrier EasyWarm Active Self-Warming BlanketK203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemK202090Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential ClaimK193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI MicroK191869Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential ClaimK190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove

View all 12 devices →

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.

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

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.

↑