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FDA 510(k)

EXUSORB(TM) GEL DRESSING

K-Number: K895606 · 1989-10-19

ApplicantControlled Therapeutics Corp.
Decision Date1989-10-19
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

EXUSORB(TM) GEL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Controlled Therapeutics Corp.. It received FDA 510(k) clearance on 1989-10-19 under 510(k) number K895606. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the EXUSORB(TM) GEL DRESSING?

EXUSORB(TM) GEL DRESSING is a medical device that received FDA 510(k) clearance on 1989-10-19. The listed applicant is Controlled Therapeutics Corp.. The 510(k) number is K895606.

When did EXUSORB(TM) GEL DRESSING receive FDA 510(k) clearance?

EXUSORB(TM) GEL DRESSING received FDA 510(k) clearance on 1989-10-19, under 510(k) number K895606.

Who is the listed applicant for EXUSORB(TM) GEL DRESSING?

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

What is the FDA product code for EXUSORB(TM) GEL DRESSING?

The FDA product code for EXUSORB(TM) GEL 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.

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Other records listing Controlled Therapeutics 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.

K896176EXUSORB(TM) DRY/WET DRESSINGK894996EXUSORB(TM) GRANULESK894274EXUSORB TRANSPARENT DRESSING

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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