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FDA 510(k)

CLINAGEL (ABSORBENT GEL)

K-Number: K860892 · 1986-07-23

ApplicantSchering Chemicals, C/O Ellis Pharmaceuticals
Decision Date1986-07-23
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

CLINAGEL (ABSORBENT GEL) is the device name listed in this FDA 510(k) record. The listed applicant is Schering Chemicals, C/O Ellis Pharmaceuticals. It received FDA 510(k) clearance on 1986-07-23 under 510(k) number K860892. 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 for Some Indications.

Frequently Asked Questions

What is the CLINAGEL (ABSORBENT GEL)?

CLINAGEL (ABSORBENT GEL) is a medical device that received FDA 510(k) clearance on 1986-07-23. The listed applicant is Schering Chemicals, C/O Ellis Pharmaceuticals. The 510(k) number is K860892.

When did CLINAGEL (ABSORBENT GEL) receive FDA 510(k) clearance?

CLINAGEL (ABSORBENT GEL) received FDA 510(k) clearance on 1986-07-23, under 510(k) number K860892.

Who is the listed applicant for CLINAGEL (ABSORBENT GEL)?

The FDA 510(k) record lists Schering Chemicals, C/O Ellis Pharmaceuticals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLINAGEL (ABSORBENT GEL)?

The FDA product code for CLINAGEL (ABSORBENT GEL) 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.

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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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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