Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5790](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5790) → BSR — Stylet, Tracheal Tube # BSR · Stylet, Tracheal Tube _Anesthesiology · 21 CFR 868.5790 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR ## Overview - **Product Code:** BSR - **Device Name:** Stylet, Tracheal Tube - **Regulation:** [21 CFR 868.5790](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5790) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K162729.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K962361.md) | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND | Laerdal Medical Corp. | Sep 5, 1996 | SESE | | [K954771](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K954771.md) | TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) | Laerdal Medical Corp. | May 9, 1996 | SESE | | [K943104](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K943104.md) | MOLLOY INTUBATING STYLETTE | Molloy Corp. | Apr 18, 1996 | SESE | | [K955238](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K955238.md) | RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE | Rusch Intl. | Feb 6, 1996 | SESE | | [K953677](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K953677.md) | LIGHTED FLEXGUIDE (MODIFICATION) | Scientific Sales Intl., Inc. | Aug 25, 1995 | SESE | | [K952100](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K952100.md) | RUSCH ENDOTRACHEAL TUBE STYLET | Rusch, Inc. | Aug 8, 1995 | SESE | | [K952266](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K952266.md) | SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE | Stebar Instrument Corp. | Jun 12, 1995 | SESE | | [K950713](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K950713.md) | AIRGUIDE STYLETTE | Polamedco, Inc. | May 17, 1995 | SESE | | [K950380](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K950380.md) | FLEXTITIP STYLETTE | Polamedco, Inc. | Feb 10, 1995 | SESE | | [K944729](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K944729.md) | STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE | Coast Medical, Inc. | Dec 21, 1994 | SESE | | [K940799](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K940799.md) | FLEXGUIDE | Scientific Sales Intl., Inc. | Aug 18, 1994 | SESE | | [K933598](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K933598.md) | ENDOSTAR(TM) STYLET | Fiberoptic Medical Products, Inc. | Jan 25, 1994 | SESE | | [K935797](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K935797.md) | SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE | Stebar Instrument Corp. | Jan 12, 1994 | SESE | | [K932081](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K932081.md) | LIGHTED INTUBATION SYLET | Aaron Medical, Inc. | Jul 27, 1993 | SESE | | [K904999](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K904999.md) | WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE | Opticon Medical, Inc. | Jan 26, 1993 | SESE | | [K922842](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K922842.md) | STYLET AND TRACHEAL LIGHTWAND (STL) | Laerdal California, Inc. | Dec 18, 1992 | SESE | | [K921128](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K921128.md) | ENDOTRACHEAL TUBE STYLET | Eastmed Enterprises, Inc. | Jun 2, 1992 | SESE | | [K914965](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K914965.md) | DISPOSABLE STYLETTE WITH END CAP | Pivic Promedco | May 27, 1992 | SESE | | [K920468](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR/K920468.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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