Silicone cap BS2314-3

• FDA 510(k) K854414 decided 12 Mar 1986 Active
• FDA GUDID UDI-DI 03700620600082 listed 7 Nov 2023 Listed

1. 12 Mar 1986 Cleared FDA 510(k) K854414
2. 7 Nov 2023 Listed FDA GUDID 03700620600082

Trade name

Silicone cap

Generic name

Rigid optical bronchoscope

Model / reference

BS2314-3

Primary DI / UDI-DI

03700620600082

510(k) Number

K854414 ↗

FDA product code

EOQ

GMDN term

Rigid optical bronchoscope

Device class

Class II

Regulation number

874.4680

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Rigid optical bronchoscope

Other devices filed under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)).

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• OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 by Olympus Medical Systems Corporation
• LoopView® B58-C by MacroLux Medical Technology Co., Ltd.
• OLYMPUS SPRAY CATHETER PW-6C-1 by The Olympus Optical Co.
• Captura Disposable Bronchoscope Biopsy Forceps by Wilson-Cook Medical, Inc.
• 490110 by Intuitive Surgical, Inc.
• RIGID FIBEROPTIC ENDOSCOPES by Kelleher Corp.
• 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE by Karl Storz Endoscopy-America, Inc.
• Single-Use Video Bronchoscope SVB11001 by Micro-Tech (Nanjing) Co., Ltd.

• Adult introducer tube BR2000-3

  Class II

  FDA 510(k) K854414 Active Cleared 12 Mar 1986 GUDID on market

• Sterilization basket without lid DJ-4561

  Class II

  FDA 510(k) K854414 Active Cleared 12 Mar 1986 GUDID on market

• Pediatric tube BT2403-3

  Class II

  FDA 510(k) K854414 Active Cleared 12 Mar 1986 GUDID on market

• Pediatric plunger BP2402-3

  Class II

  FDA 510(k) K854414 Active Cleared 12 Mar 1986 GUDID on market

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