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FDA 510(k)

TIPSTOP(TM)

K-Number: K896068 · 1990-09-10

ApplicantGambro-Hospal, Inc.
Decision Date1990-09-10
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TIPSTOP(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Gambro-Hospal, Inc.. It received FDA 510(k) clearance on 1990-09-10 under 510(k) number K896068. 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 TIPSTOP(TM)?

TIPSTOP(TM) is a medical device that received FDA 510(k) clearance on 1990-09-10. The listed applicant is Gambro-Hospal, Inc.. The 510(k) number is K896068.

When did TIPSTOP(TM) receive FDA 510(k) clearance?

TIPSTOP(TM) received FDA 510(k) clearance on 1990-09-10, under 510(k) number K896068.

Who is the listed applicant for TIPSTOP(TM)?

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

What is the FDA product code for TIPSTOP(TM)?

The FDA product code for TIPSTOP(TM) 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 Gambro-Hospal, 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.

K902588BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MODK901368HEMOSPAL KITS A1, A2D, AO, & A1D

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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