Silicone cap BS2308-3

• FDA 510(k) K854414 decided 12 Mar 1986 Active
• FDA GUDID UDI-DI 03700620600143 listed 26 Oct 2023 Listed

1. 12 Mar 1986 Cleared FDA 510(k) K854414
2. 26 Oct 2023 Listed FDA GUDID 03700620600143

Trade name

Silicone cap

Generic name

Rigid optical bronchoscope

Model / reference

BS2308-3

Primary DI / UDI-DI

03700620600143

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)).

• 10101FA by Karl Storz SE & CO. KG
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• THROAT MICROPHONE MAJ-2549 N6218900 by Olympus Medical Systems Corporation
• LungVision Tool Bridge LV2055002 by Bodyvision Medical, Ltd.
• FIBERBRONCHOSCOPE (PENTAX FB-17A) by Pilling Co.
• aScope™ 4 Broncho Regular Sampler Set 5.0/2.2 477501000 by Ambu A/S
• BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM by Olympus Corp.
• BRONCHIAL CATHETER SYSTEM by Broncus Technologies, Inc.
• VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH by Vision-Sciences, Inc.
• B7 2C Occlusion Balloon by Spiration, Inc.

• 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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