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)

AQUACEL HYDROFIBER WOUND DRESSING

K-Number: K982116 · 1998-09-08

ApplicantConvatec, A Bristol-Myers Squibb Co.
Decision Date1998-09-08
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AQUACEL HYDROFIBER WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Bristol-Myers Squibb Co.. It received FDA 510(k) clearance on 1998-09-08 under 510(k) number K982116. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUACEL HYDROFIBER WOUND DRESSING?

AQUACEL HYDROFIBER WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1998-09-08. The listed applicant is Convatec, A Bristol-Myers Squibb Co.. The 510(k) number is K982116.

When did AQUACEL HYDROFIBER WOUND DRESSING receive FDA 510(k) clearance?

AQUACEL HYDROFIBER WOUND DRESSING received FDA 510(k) clearance on 1998-09-08, under 510(k) number K982116.

Who is the listed applicant for AQUACEL HYDROFIBER WOUND DRESSING?

The FDA 510(k) record lists Convatec, A Bristol-Myers Squibb Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUACEL HYDROFIBER WOUND DRESSING?

The FDA product code for AQUACEL HYDROFIBER WOUND DRESSING is KMF.

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 Convatec, A Bristol-Myers Squibb Co. 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.

K032734CONVATEC FECAL MANAGEMENT SYSTEMK990368DUODERM HYDROACTIVE GEL WOUND DRESSINGK973806DUODERM HYDROACTIVE GELK973807DUODERM HYDROACTIVE PASTEK973717COMBIDERM ACDK973716DUODERM EXTRA THIN CGF DRESSING

View all 10 devices →

Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, 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.

↑