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FDA 510(k)

SPYROSORB FOAM ISLAND WOUND DRESSING

K-Number: K980673 · 1998-05-21

ApplicantInnovative Technologies (Us), Inc.
Decision Date1998-05-21
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

SPYROSORB FOAM ISLAND WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Technologies (Us), Inc.. It received FDA 510(k) clearance on 1998-05-21 under 510(k) number K980673. 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 SPYROSORB FOAM ISLAND WOUND DRESSING?

SPYROSORB FOAM ISLAND WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1998-05-21. The listed applicant is Innovative Technologies (Us), Inc.. The 510(k) number is K980673.

When did SPYROSORB FOAM ISLAND WOUND DRESSING receive FDA 510(k) clearance?

SPYROSORB FOAM ISLAND WOUND DRESSING received FDA 510(k) clearance on 1998-05-21, under 510(k) number K980673.

Who is the listed applicant for SPYROSORB FOAM ISLAND WOUND DRESSING?

The FDA 510(k) record lists Innovative Technologies (Us), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPYROSORB FOAM ISLAND WOUND DRESSING?

The FDA product code for SPYROSORB FOAM ISLAND 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.

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Other records listing Innovative Technologies (Us), Inc. 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.

K982804SPYROGEL HYDROGEL WOUND AND BURN DRESSINGK974520SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM

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.

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