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FDA 510(k)

BANDAGE REMOVAL STRIP

K-Number: K895884 · 1989-12-27

ApplicantKut-Guard, Inc.
Decision Date1989-12-27
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BANDAGE REMOVAL STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Kut-Guard, Inc.. It received FDA 510(k) clearance on 1989-12-27 under 510(k) number K895884. 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 BANDAGE REMOVAL STRIP?

BANDAGE REMOVAL STRIP is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Kut-Guard, Inc.. The 510(k) number is K895884.

When did BANDAGE REMOVAL STRIP receive FDA 510(k) clearance?

BANDAGE REMOVAL STRIP received FDA 510(k) clearance on 1989-12-27, under 510(k) number K895884.

Who is the listed applicant for BANDAGE REMOVAL STRIP?

The FDA 510(k) record lists Kut-Guard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BANDAGE REMOVAL STRIP?

The FDA product code for BANDAGE REMOVAL STRIP is KGX.

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 Kut-Guard, 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.

K895092KUT-SHIELD

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

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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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