BSR · Stylet, Tracheal Tube
Anesthesiology · 21 CFR 868.5790 · Class 1
Overview
| Product Code | BSR |
|---|---|
| Device Name | Stylet, Tracheal Tube |
| Regulation | 21 CFR 868.5790 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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 | Aug 11, 2017 | SESE |
| K962361 | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND | Laerdal Medical Corp. | Sep 5, 1996 | SESE |
| K954771 | TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) | Laerdal Medical Corp. | May 9, 1996 | SESE |
| K943104 | MOLLOY INTUBATING STYLETTE | Molloy Corp. | Apr 18, 1996 | SESE |
| K955238 | RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE | Rusch Intl. | Feb 6, 1996 | SESE |
| K953677 | LIGHTED FLEXGUIDE (MODIFICATION) | Scientific Sales Intl., Inc. | Aug 25, 1995 | SESE |
| K952100 | RUSCH ENDOTRACHEAL TUBE STYLET | Rusch, Inc. | Aug 8, 1995 | SESE |
| K952266 | SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE | Stebar Instrument Corp. | Jun 12, 1995 | SESE |
| K950713 | AIRGUIDE STYLETTE | Polamedco, Inc. | May 17, 1995 | SESE |
| K950380 | FLEXTITIP STYLETTE | Polamedco, Inc. | Feb 10, 1995 | SESE |
| K944729 | STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE | Coast Medical, Inc. | Dec 21, 1994 | SESE |
| K940799 | FLEXGUIDE | Scientific Sales Intl., Inc. | Aug 18, 1994 | SESE |
| K933598 | ENDOSTAR(TM) STYLET | Fiberoptic Medical Products, Inc. | Jan 25, 1994 | SESE |
| K935797 | SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE | Stebar Instrument Corp. | Jan 12, 1994 | SESE |
| K932081 | LIGHTED INTUBATION SYLET | Aaron Medical, Inc. | Jul 27, 1993 | SESE |
| K904999 | WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE | Opticon Medical, Inc. | Jan 26, 1993 | SESE |
| K922842 | STYLET AND TRACHEAL LIGHTWAND (STL) | Laerdal California, Inc. | Dec 18, 1992 | SESE |
| K921128 | ENDOTRACHEAL TUBE STYLET | Eastmed Enterprises, Inc. | Jun 2, 1992 | SESE |
| K914965 | DISPOSABLE STYLETTE WITH END CAP | Pivic Promedco | May 27, 1992 | SESE |
| K920468 | AUGUSTINE STYLET | Augustine Medical, Inc. | Apr 23, 1992 | SESE |
Top Applicants
- Augustine Medical, Inc. — 3 clearances
- Scientific Sales Intl., Inc. — 3 clearances
- Ackrad Laboratories — 2 clearances
- Laerdal Medical Corp. — 2 clearances
- Polamedco, Inc. — 2 clearances
