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FDA 510(k)

CURAGEL HYDROGEL WOUND DRESSING

K-Number: K950412 · 1995-03-24

ApplicantKendall Healthcare Products Co. Div.Of Tyco Health
Decision Date1995-03-24
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CURAGEL HYDROGEL WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K950412. The device is classified under product code NAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CURAGEL HYDROGEL WOUND DRESSING?

CURAGEL HYDROGEL WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. The 510(k) number is K950412.

When did CURAGEL HYDROGEL WOUND DRESSING receive FDA 510(k) clearance?

CURAGEL HYDROGEL WOUND DRESSING received FDA 510(k) clearance on 1995-03-24, under 510(k) number K950412.

Who is the listed applicant for CURAGEL HYDROGEL WOUND DRESSING?

The FDA 510(k) record lists Kendall Healthcare Products Co. Div.Of Tyco Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CURAGEL HYDROGEL WOUND DRESSING?

The FDA product code for CURAGEL HYDROGEL WOUND DRESSING is NAE.

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Other records listing Kendall Healthcare Products Co. Div.Of Tyco Health 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.

K973763KENDALL CURITY IODOFORM PACKING STRIPK973511KENDALL CURITY PETROLATUM GAUZEK973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)K973619KENDALL CURITY NON-ADHERING DRESSINGK973509KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSINGK973546KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER

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Related Devices (Code: NAE)

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.

K083721MODIFICATION TO ZENIEVARiver'S Edge Pharmaceuticals, LLCK082865MODIFICATION TO ZENIEVAGorbec Pharmaceutical Services, Inc.K073246ZENIEVAGorbec Pharmaceutical Services, Inc.K992094GILTECH PLUS HYDROGEL SKIN DRESSINGGiltech Plus, Inc.K991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGDermaphylyx, Inc.K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESLudlow Technical Products

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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