FDA 510(k)

11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE

K-Number: K931442 · 1995-01-24

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1995-01-24

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1995-01-24 under 510(k) number K931442. 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 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE?

11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K931442.

When did 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE receive FDA 510(k) clearance?

11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE received FDA 510(k) clearance on 1995-01-24, under 510(k) number K931442.

Who is the listed applicant for 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE?

The FDA product code for 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE is EOQ.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

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Related Devices (Code: EOQ)

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/S K2540263.8mm 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

View on FDA Database →

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