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)

XEROFORM DRESSING

K-Number: K813535 · 1982-02-04

ApplicantW.G. Whitney Corp.
Decision Date1982-02-04
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

XEROFORM DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is W.G. Whitney Corp.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K813535. 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 XEROFORM DRESSING?

XEROFORM DRESSING is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is W.G. Whitney Corp.. The 510(k) number is K813535.

When did XEROFORM DRESSING receive FDA 510(k) clearance?

XEROFORM DRESSING received FDA 510(k) clearance on 1982-02-04, under 510(k) number K813535.

Who is the listed applicant for XEROFORM DRESSING?

The FDA 510(k) record lists W.G. Whitney Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XEROFORM DRESSING?

The FDA product code for XEROFORM DRESSING 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing W.G. Whitney Corp. 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.

K834532STERILE WET DRESSING PACKK810406STERILE WET DRESSING PACKK803299COLD/HOT PACKK800907TOMAC WET DRESSING WARMERK781322STERILE WET DRESSING PACKK770387UNICATCH

View all 7 devices →

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.

↑