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FDA 510(k)

INTUBATION ENDOSCOPE AND INTRODUCER SHEATH

K-Number: K970107 · 1997-11-18

ApplicantUrohealth Systems, Inc.
Decision Date1997-11-18
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTUBATION ENDOSCOPE AND INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Urohealth Systems, Inc.. It received FDA 510(k) clearance on 1997-11-18 under 510(k) number K970107. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTUBATION ENDOSCOPE AND INTRODUCER SHEATH?

INTUBATION ENDOSCOPE AND INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 1997-11-18. The listed applicant is Urohealth Systems, Inc.. The 510(k) number is K970107.

When did INTUBATION ENDOSCOPE AND INTRODUCER SHEATH receive FDA 510(k) clearance?

INTUBATION ENDOSCOPE AND INTRODUCER SHEATH received FDA 510(k) clearance on 1997-11-18, under 510(k) number K970107.

Who is the listed applicant for INTUBATION ENDOSCOPE AND INTRODUCER SHEATH?

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

What is the FDA product code for INTUBATION ENDOSCOPE AND INTRODUCER SHEATH?

The FDA product code for INTUBATION ENDOSCOPE AND INTRODUCER SHEATH is EOQ.

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.

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Other records listing Urohealth Systems, 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.

K980617MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTERK972510PIVOTAL SCISSOR

Related Devices (Code: EOQ)

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.

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/SK2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm 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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