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)

SUCTION SYSTEM

K-Number: K861306 · 1986-06-09

ApplicantAxiom Medical, Inc.
Decision Date1986-06-09
Product CodeGEA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Medical, Inc.. It received FDA 510(k) clearance on 1986-06-09 under 510(k) number K861306. The device is classified under product code GEA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUCTION SYSTEM?

SUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 1986-06-09. The listed applicant is Axiom Medical, Inc.. The 510(k) number is K861306.

When did SUCTION SYSTEM receive FDA 510(k) clearance?

SUCTION SYSTEM received FDA 510(k) clearance on 1986-06-09, under 510(k) number K861306.

Who is the listed applicant for SUCTION SYSTEM?

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

What is the FDA product code for SUCTION SYSTEM?

The FDA product code for SUCTION SYSTEM is GEA.

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 Axiom Medical, 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.

K993592AXIOM MULTIPURPOSE WOUND DRAINK971851INTERPLEURAL ANESTHESIA CATHETERK965146FLAT CLOSED WOUND DRAIN WITH TROCARK934895GLASSMAN SILICONE CATHETERK922760ATRAUM WOUND DRESSING--MODIFICATIONK905422PVC ROUND WOUND DRAINS

View all 28 devices →

Related Devices (Code: GEA)

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.

K003965MRI SAFE INSTRUMENTSAesculap, Inc.K982472GENICON TROCARGenicon, LCK954599CONMED TROGARD ELECTRONIC TROCAR SYSTEMConmedcorpK922460ORIGIN SECONDARY CANNULA AND TROCAROrigin Medsystems, Inc.K920110ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVEETHICON, Inc.K911262DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCERETHICON, 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.

↑