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)

SURGIFLATOR-40

K-Number: K001533 · 2000-07-31

ApplicantW.O.M. Gmhb
Decision Date2000-07-31
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SURGIFLATOR-40 is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. Gmhb. It received FDA 510(k) clearance on 2000-07-31 under 510(k) number K001533. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIFLATOR-40?

SURGIFLATOR-40 is a medical device that received FDA 510(k) clearance on 2000-07-31. The listed applicant is W.O.M. Gmhb. The 510(k) number is K001533.

When did SURGIFLATOR-40 receive FDA 510(k) clearance?

SURGIFLATOR-40 received FDA 510(k) clearance on 2000-07-31, under 510(k) number K001533.

Who is the listed applicant for SURGIFLATOR-40?

The FDA 510(k) record lists W.O.M. Gmhb as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGIFLATOR-40?

The FDA product code for SURGIFLATOR-40 is HIF.

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

Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems 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.

↑