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FDA 510(k)

OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)

K-Number: K895408 · 1989-12-14

ApplicantSmith & Nephew United, Inc.
Decision Date1989-12-14
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew United, Inc.. It received FDA 510(k) clearance on 1989-12-14 under 510(k) number K895408. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)?

OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) is a medical device that received FDA 510(k) clearance on 1989-12-14. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K895408.

When did OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) receive FDA 510(k) clearance?

OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) received FDA 510(k) clearance on 1989-12-14, under 510(k) number K895408.

Who is the listed applicant for OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)?

The FDA 510(k) record lists Smith & Nephew United, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)?

The FDA product code for OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) is KGX.

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Other records listing Smith & Nephew United, 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.

K963096ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSINGK961775PROFORE FOUR-LAYER BANDAGE SYSTEM KITK945330ALLEVYN ADHESIVEK943619CAVI-CARE CONFORMING FOAM DRESSINGK942748INTRASITEK935705ALLEVYN ISLAND WOUND DRESSING

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Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, 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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