Bronchoscope Accessory
CONTROL INSTRUMENT FOR BRONCH. OD 28MM WL 429mm, for use with bronchoscopes, flexible forceps, scissors, cytology brushes, along with other endoscopic accessories, for use with telescopes Ø…
CONTROL INSTRUMENT FOR BRONCH. OD 28MM WL 429mm, for use with bronchoscopes, flexible forceps, scissors, cytology brushes, along with other endoscopic accessories, for use with telescopes Ø 5.5mm, reusable
5manufacturers in China registered for this device type
42catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | KTI |
| Device type | Bronchoscope Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2024-11-21 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C |
| Sizes | Lumen/inner diameter 0.8 to 12 mm; length 94 to 470 mm; outer diameter 28 mm |
| Distribution end date | 2025-01-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8214074 | Lumen/Inner Diameter 7.5 mm | Withdrawn | |
| 8214126 | Lumen/Inner Diameter 12 mm | Withdrawn | |
| 825144030 | Lumen/Inner Diameter 4.4 mm | Withdrawn | |
| 825143520 | Lumen/Inner Diameter 3.7 mm | Withdrawn | |
| 8238501 | Withdrawn | ||
| 825105025 | Lumen/Inner Diameter 5.2 mm | Withdrawn | |
| 8215713 | Length 211 mm | Withdrawn | |
| 825143528 | Lumen/Inner Diameter 3.7 mm | Withdrawn | |
| 825103520 | Lumen/Inner Diameter 3.7 mm | Withdrawn | |
| 8215715 | Length 124 mm | Withdrawn | |
| 825106035 | Lumen/Inner Diameter 6.2 mm | Withdrawn | |
| 825146535 | Lumen/Inner Diameter 6.7 mm | Withdrawn | |
| 825100011 | Length 450 mm | Withdrawn | |
| 825142716 | Lumen/Inner Diameter 2.8 mm | Withdrawn | |
| 8215711 | Length 98 mm | Withdrawn | |
| 825144530 | Lumen/Inner Diameter 4.7 mm | Withdrawn | |
| 8466801 | Outer Diameter 28 mm | Withdrawn | |
| 825104525 | Lumen/Inner Diameter 4.7 mm | Withdrawn | |
| 825010 | Length 470 mm | Withdrawn | |
| 8238502 | Withdrawn | ||
| 820518 | 2 | Withdrawn | |
| 825144524 | Lumen/Inner Diameter 4.7 mm | Withdrawn | |
| 825105530 | Lumen/Inner Diameter 5.7 mm | Withdrawn | |
| 825145030 | Lumen/Inner Diameter 5.2 mm | Withdrawn | |
| 825144525 | Lumen/Inner Diameter 4.7 mm | Withdrawn | |
| 825103528 | Lumen/Inner Diameter 3.7 mm | Withdrawn | |
| 825144025 | Lumen/Inner Diameter 4.4 mm | Withdrawn | |
| 825146030 | Lumen/Inner Diameter 6.2 mm | Withdrawn | |
| 825103016 | Lumen/Inner Diameter 3.2 mm | Withdrawn | |
| 825105030 | Lumen/Inner Diameter 5.2 mm | Withdrawn | |
| 8214072 | Lumen/Inner Diameter 7.5 mm | Withdrawn | |
| 8215716 | Length 174 mm | Withdrawn | |
| 829402 | Length 113 mm | Withdrawn | |
| 825104030 | Lumen/Inner Diameter 4.4 mm | Withdrawn | |
| 825103028 | Lumen/Inner Diameter 3.2 mm | Withdrawn | |
| 825001 | Withdrawn | ||
| 825104524 | Lumen/Inner Diameter 4.7 mm | Withdrawn | |
| 8214082 | Lumen/Inner Diameter 8.5 mm | Withdrawn | |
| 825104530 | Lumen/Inner Diameter 4.7 mm | Withdrawn | |
| 825104025 | Lumen/Inner Diameter 4.4 mm | Withdrawn | |
| 825106535 | Lumen/Inner Diameter 6.7 mm | Withdrawn | |
| 8215714 | Length 94 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MultiStage® | Dongguan TT Medical, Inc. | 24 |
| Elation™ | Merit Medical Systems, Inc. | 23 |
| Inspira AIR | Acclarent, Inc. | 14 |
| Texas | Richard Wolf Gmbh | 10 |
| Trachealator Non-occlusive Airway Dilation Balloon | Disa Medinotec (PTY) Ltd | 9 |
| Pilling | Teleflex Medical LLC | 8 |
| CRE Pulmonary | Boston Scientific Corporation | 6 |
| Single Use Aspiration Needle | Olympus Medical Systems Corp. | 5 |
| Cook | Cook Incorporated | 3 |
| Areus(TM) Endobronchial Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
| Trident(TM) Endobronchial Ultrasound Biopsy Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
| Compass Steerable Needle | Serpex Medical, Inc. | 2 |
Showing 12 of 37. All products under Bronchoscope Accessory
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2018-10-17 | Class II | Process control | There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen. | 873 units worldwide (468 units within the US) |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.