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FDA 510(k)

Biatain Silicone Ag

K-Number: K191536 · 2020-02-21

ApplicantColoplast A/S
Decision Date2020-02-21
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Biatain Silicone Ag is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K191536. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biatain Silicone Ag?

Biatain Silicone Ag is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Coloplast A/S. The 510(k) number is K191536.

When did Biatain Silicone Ag receive FDA 510(k) clearance?

Biatain Silicone Ag received FDA 510(k) clearance on 2020-02-21, under 510(k) number K191536.

Who is the listed applicant for Biatain Silicone Ag?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biatain Silicone Ag?

The FDA product code for Biatain Silicone Ag is FRO. This falls under the Anesthesiology category.

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.

NCT05619003Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at RiskCOMPLETEDNCT04115605A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary IncontinenceTERMINATEDNCT06985888New Coating for Urinary Intermittent CathetersCOMPLETED

Other records listing Coloplast A/S 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.

K262045Luja SoftK221874Altis Single Incision Sling SystemK220420Saffron Fixation SystemK181811ReTrace Ureteral Access SheathK173527Digitex Delivery Device

Related Devices (Code: FRO)

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, 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.

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