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)

CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM

K-Number: K992126 · 1999-08-03

ApplicantCircon Corp.
Decision Date1999-08-03
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Circon Corp.. It received FDA 510(k) clearance on 1999-08-03 under 510(k) number K992126. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM?

CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-03. The listed applicant is Circon Corp.. The 510(k) number is K992126.

When did CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM receive FDA 510(k) clearance?

CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM received FDA 510(k) clearance on 1999-08-03, under 510(k) number K992126.

Who is the listed applicant for CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM?

The FDA 510(k) record lists Circon Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM?

The FDA product code for CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM is GCX.

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 Circon Corp. 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.

K992544TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEMK981611SNAP-N-PEEL INTRODUCERSK980972RIGID CULDOSCOPE AND ACCESSORIESK973820USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODEK964594VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)

Related Devices (Code: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco HealthK963648STRYKER SUCTION REGULATORStryker Endoscopy

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.

↑