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FDA 510(k)

SURE-FLO INSUFFLATION TUBING

K-Number: K930696 · 1994-04-19

ApplicantO.R. Resources, Inc.
Decision Date1994-04-19
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SURE-FLO INSUFFLATION TUBING is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Resources, Inc.. It received FDA 510(k) clearance on 1994-04-19 under 510(k) number K930696. 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 SURE-FLO INSUFFLATION TUBING?

SURE-FLO INSUFFLATION TUBING is a medical device that received FDA 510(k) clearance on 1994-04-19. The listed applicant is O.R. Resources, Inc.. The 510(k) number is K930696.

When did SURE-FLO INSUFFLATION TUBING receive FDA 510(k) clearance?

SURE-FLO INSUFFLATION TUBING received FDA 510(k) clearance on 1994-04-19, under 510(k) number K930696.

Who is the listed applicant for SURE-FLO INSUFFLATION TUBING?

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

What is the FDA product code for SURE-FLO INSUFFLATION TUBING?

The FDA product code for SURE-FLO INSUFFLATION TUBING 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 O.R. Resources, 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.

K953131EXUSORB STERILE ABSORBENTK945217HYDROGEL DRESSINGK944119SURE-FLO IRRIGATION Y TUBING SET

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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