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)

LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET

K-Number: K873435 · 1987-10-05

ApplicantLevel 1 Technologies, Inc.
Decision Date1987-10-05
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET is the device name listed in this FDA 510(k) record. The listed applicant is Level 1 Technologies, Inc.. It received FDA 510(k) clearance on 1987-10-05 under 510(k) number K873435. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET?

LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET is a medical device that received FDA 510(k) clearance on 1987-10-05. The listed applicant is Level 1 Technologies, Inc.. The 510(k) number is K873435.

When did LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET receive FDA 510(k) clearance?

LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET received FDA 510(k) clearance on 1987-10-05, under 510(k) number K873435.

Who is the listed applicant for LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET?

The FDA 510(k) record lists Level 1 Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET?

The FDA product code for LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET is KOD.

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 Level 1 Technologies, 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.

K942844LEVEL 1 BLOOD STREAM RECOVERY SYSTEMK942271LEVEL 1* INJECT NEEDLE-FREE INJECTION SITEK936223PRESSURE IRRIGATING SYSTEMK911383HOTLINE FLUID WARMER

Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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.

↑