FDA 510(k)

Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)

Numéro K : K251752 · 2025-08-27

DemandeurShanghai AnQing Medical Instrument Co., Ltd.

Date de décision2025-08-27

Code produitEOQ

Comité consultatifEN

DécisionSubstantially Equivalent

Résumé du dispositif

Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K251752. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)?

Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K251752.

When did Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) receive FDA 510(k) clearance?

Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) received FDA 510(k) clearance on 2025-08-27, under 510(k) number K251752.

Who is the listed applicant for Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)?

The FDA 510(k) record lists Shanghai AnQing Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)?

The FDA product code for Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) is EOQ.

Essais cliniques associés

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Autres dossiers indiquant Shanghai AnQing Medical Instrument Co., Ltd. en tant que demandeur

K254251InnovexView (GC146-17, GC150-20, GC155-23)K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)K231105Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

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Dispositifs connexes (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

Source officielle

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