FDA product code SBS: Laryngeal Injection Set With Led Light
SBS is the FDA product code for laryngeal injection set with led light. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under SBS, 1 in the last five years. The average 510(k) review took 352 days (median 352); 352 days on average over the last three years.
Definition
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
Classification
| Field | Value |
|---|---|
| Device name | Laryngeal Injection Set With Led Light |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
510(k) clearances per year for SBS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 352 |
Compare with all 510(k) review times · Search every SBS clearance
Top SBS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Solmedix Co., Ltd. | 1 | 2024-07-10 |
Most recent SBS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232177 | Solmedix Co., Ltd. | Lightin System, Lightin, Lightin Generator | 2024-07-10 | 352 |
Recalls for SBS devices
openFDA lists no recalls for product code SBS.
Frequently asked questions
What is FDA product code SBS?
SBS is the FDA product code for laryngeal injection set with led light. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is SBS?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code SBS?
Across 1 cleared submissions the average was 352 days from receipt to decision (median 352).
Which companies have the most SBS clearances?
Solmedix Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SBS
- Run a recall and safety report across every SBS manufacturer
- Watch product code SBS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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