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FDA 510(k)

HI-TEC CO2 INSUFFLATOR TYPE 1300

K-Number: K955477 · 1997-08-06

ApplicantHi Tec Medical Vertriebs-GmbH Fur Innovative Mediz
Decision Date1997-08-06
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HI-TEC CO2 INSUFFLATOR TYPE 1300 is the device name listed in this FDA 510(k) record. The listed applicant is Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K955477. 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 HI-TEC CO2 INSUFFLATOR TYPE 1300?

HI-TEC CO2 INSUFFLATOR TYPE 1300 is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz. The 510(k) number is K955477.

When did HI-TEC CO2 INSUFFLATOR TYPE 1300 receive FDA 510(k) clearance?

HI-TEC CO2 INSUFFLATOR TYPE 1300 received FDA 510(k) clearance on 1997-08-06, under 510(k) number K955477.

Who is the listed applicant for HI-TEC CO2 INSUFFLATOR TYPE 1300?

The FDA 510(k) record lists Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI-TEC CO2 INSUFFLATOR TYPE 1300?

The FDA product code for HI-TEC CO2 INSUFFLATOR TYPE 1300 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

Other records listing Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz 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.

K930013CO2 INSUFFLATOR 1100

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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