Product code BSR
- Device name
- Stylet, Tracheal Tube
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5790
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip | Cook Incorporated | 2017-08-11 |
| K962361 | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND | Laerdal Medical Corp. | 1996-09-05 |
| K954771 | TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) | Laerdal Medical Corp. | 1996-05-09 |
| K943104 | MOLLOY INTUBATING STYLETTE | Molloy Corp. | 1996-04-18 |
| K955238 | RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE | Rusch Intl. | 1996-02-06 |
| K953677 | LIGHTED FLEXGUIDE (MODIFICATION) | Scientific Sales Intl., Inc. | 1995-08-25 |
| K952100 | RUSCH ENDOTRACHEAL TUBE STYLET | Rusch, Inc. | 1995-08-08 |
| K952266 | SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE | Stebar Instrument Corp. | 1995-06-12 |
| K950713 | AIRGUIDE STYLETTE | Polamedco, Inc. | 1995-05-17 |
| K950380 | FLEXTITIP STYLETTE | Polamedco, Inc. | 1995-02-10 |
| K944729 | STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE | Coast Medical, Inc. | 1994-12-21 |
| K940799 | FLEXGUIDE | Scientific Sales Intl., Inc. | 1994-08-18 |
| K933598 | ENDOSTAR(TM) STYLET | Fiberoptic Medical Products, Inc. | 1994-01-25 |
| K935797 | SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE | Stebar Instrument Corp. | 1994-01-12 |
| K932081 | LIGHTED INTUBATION SYLET | Aaron Medical, Inc. | 1993-07-27 |
| K904999 | WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE | Opticon Medical, Inc. | 1993-01-26 |
| K922842 | STYLET AND TRACHEAL LIGHTWAND (STL) | Laerdal California, Inc. | 1992-12-18 |
| K921128 | ENDOTRACHEAL TUBE STYLET | Eastmed Enterprises, Inc. | 1992-06-02 |
| K914965 | DISPOSABLE STYLETTE WITH END CAP | Pivic Promedco | 1992-05-27 |
| K920468 | AUGUSTINE STYLET | Augustine Medical, Inc. | 1992-04-23 |
| K912690 | AUGUSTINE GUIDE(TM) KIT | Augustine Medical, Inc. | 1991-09-04 |
| K910659 | AUGUSTINE STYLET | Augustine Medical, Inc. | 1991-05-17 |
| K905133 | STYLET TRACHAEL TUBE | Medical Devices, Inc. | 1991-04-22 |
| K905052 | BIVONA ENDOTRACHEAL TUBE STYLET | Bivona Medical Technologies | 1991-04-02 |
| K902180 | TRACHEAL TUBE STYLET | Sims Surgical, Inc. | 1990-07-19 |
| K865108 | N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE | Ackrad Laboratories | 1987-02-10 |
| K844557 | ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE | Ackrad Laboratories | 1984-12-17 |
| K843490 | TUBE-STAT | Concept, Inc. | 1984-10-04 |
| K832773 | SHERI-I-SLIP INTUBATING STYLET | Sheridan Catheter Corp. | 1983-09-12 |
| K802416 | SALEM/RESCE INTUBATION GUIDE | Scientific Sales Intl., Inc. | 1980-10-23 |
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| 10888277723788 | Medline | MEDLINE INDUSTRIES, INC. | 2024-04-24 |
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| 10190752147522 | Vital Signs™ | AIRLIFE | 2022-08-22 |
| 10190752147539 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2022-08-22 |
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| 10629160000018 | INTROES POCKET BOUGIE | BOMImed Inc | 2021-08-06 |
| 10888277400696 | Medline | MEDLINE INDUSTRIES, INC. | 2021-07-03 |
| 10888277400665 | Medline | MEDLINE INDUSTRIES, INC. | 2021-07-03 |
| 10888277400672 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-26 |
| 10190752145184 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752145207 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752145191 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 08885009190196 | APA™ Stylet | VENNER MEDICAL (SINGAPORE) PTE. LTD. | 2019-02-25 |
| 14026704617316 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-20 |
| 14026704617323 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-20 |
| 14026704617330 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-20 |
| 14026704617347 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-20 |
| 14026704617354 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-20 |
| 14026704612939 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 14026704612946 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 10884522004091 | Shiley | Covidien LP | 2018-08-19 |
| 10884522004084 | Shiley | Covidien LP | 2018-08-19 |
| 10885380103094 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-14 |
| 10885380026874 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-14 |
| 10885380026867 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-14 |