FDA Product Code SBS: Laryngeal Injection Set With Led Light
A Light Guided Laryngeal Injection Set Is An Ear, Nose, And Throat Manual Surgical Instrument And Is One Of A Variety Of Devices Intended For Use In Surgical Procedures To Examine Or Treat The Bronchus, Esophagus, Trachea, Larynx, Pharynx, Nasal And Paranasal Sinus, Or Ear. This Generic Type Of Device Includes The Esophageal Dilator; Tracheal Bistour (a Long, Narrow Surgical Knife); Tracheal Dilator; Tracheal Hook; Laryngeal Injection Set; Laryngeal Knife; Laryngeal Saw; Laryngeal Trocar; Laryngectomy Tube; Adenoid Curette; Adenotome; Metal Tongue Depressor; Mouth Gag; Oral Screw; Salpingeal Curette; Tonsillectome; Tonsil Guillotine; Tonsil Screw; Tonsil Snare; Tonsil Suction Tube; Tonsil Suturing Hook; Antom Reforator; Ethmoid Curette; Frontal Sinus-rasp; Nasal Curette; Nasal Rasp; Nasal Rongeur; Nasal Saw; Nasal Scissors; Nasal Snare; Sinus Irrigator; Sinus Trephine; Ear Curette; Ear Excavator; Ear Rasp; Ear Scissor, Ear Snare; Ear Spoon; Ear Suction Tube; Malleous Ripper; Mastoid Gauge; Microsurgical Ear Chisel; Myringotomy Tube Inserter; Ossici Holding Clamp; Sacculotomy Tack Inserter; Vein Press; Wire Ear Loop; Microrule; Mirror; Mobilizer; Ear, Nose, And Throat Punch; Ear, Nose And Throat Knife; And Ear, Nose, And Throat Trocar
Leading manufacturers include Solmedix Co., Ltd..
FDA 510(k) Cleared Laryngeal Injection Set With Led Light Devices (Product Code SBS)
About Product Code SBS - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SBS since 2024, with 1 receiving FDA clearance (average review time: 352 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SBS devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →