Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GUTTAFLOW

K-Number: K032662 · 2003-11-03

ApplicantColtene/Whaledent GmbH & Co. KG
Decision Date2003-11-03
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GUTTAFLOW is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent GmbH & Co. KG. It received FDA 510(k) clearance on 2003-11-03 under 510(k) number K032662. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUTTAFLOW?

GUTTAFLOW is a medical device that received FDA 510(k) clearance on 2003-11-03. The listed applicant is Coltene/Whaledent GmbH & Co. KG. The 510(k) number is K032662.

When did GUTTAFLOW receive FDA 510(k) clearance?

GUTTAFLOW received FDA 510(k) clearance on 2003-11-03, under 510(k) number K032662.

Who is the listed applicant for GUTTAFLOW?

The FDA 510(k) record lists Coltene/Whaledent GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUTTAFLOW?

The FDA product code for GUTTAFLOW is KIF.

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 Coltene/Whaledent GmbH & Co. KG 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.

K041023STAY-PUT IMPREGNATED

Related Devices (Code: KIF)

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.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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.

↑