KAL · Retractor, Ent
Ear, Nose, Throat · 21 CFR 874.4420 · Class 1
Overview
| Product Code | KAL |
|---|---|
| Device Name | Retractor, Ent |
| Regulation | 21 CFR 874.4420 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
An ear, nose, and throat manual surgical instrument 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 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 § 874.9.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K870758 | SMALL MASTOID RETRACTOR | Treace Medical, Inc. | Mar 4, 1987 | SESE |
| K833604 | ADJUSTABLE FORK RETRACTOR | Microtek Medical, Inc. | Jan 3, 1984 | SESE |
| K772392 | ALLPORT MASTOID RETRACTORS | Edward Weck, Inc. | Jan 17, 1978 | SESE |
| K772381 | RING HANDLE & RETRACTORS | Edward Weck, Inc. | Jan 17, 1978 | SESE |
| K760851 | CONVERSE ALTAR RETRACTOR | V. Mueller O.V. Baxter Healthcare Corp. | Mar 10, 1977 | SESE |
Top Applicants
- Edward Weck, Inc. — 2 clearances
- V. Mueller O.V. Baxter Healthcare Corp. — 1 clearance
- Treace Medical, Inc. — 1 clearance
- Microtek Medical, Inc. — 1 clearance
