KAI · Mirror, Ent
Ear, Nose, Throat · 21 CFR 874.4420 · Class 1
Overview
| Product Code | KAI |
|---|---|
| Device Name | Mirror, 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 (9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K833601 | ANTRUM & ATTIC MIRROR | Microtek Medical, Inc. | Jan 3, 1984 | SESE |
| K823915 | MIRROR TIP | Treace Medical, Inc. | Jan 21, 1983 | SESE |
| K822374 | BUCKINGHAM ATTIC & ANTRUM MIRROR | Treace Medical, Inc. | Sep 9, 1982 | SESE |
| K822261 | LARYNGEAL MIRRORS | Kelleher Corp. | Aug 30, 1982 | SESE |
| K822191 | HEAD MIRROR WITH HEADBAND | Kelleher Corp. | Aug 20, 1982 | SESE |
| K820354 | ATMOS MIRROR WARMER | Jedmed Instrument Co. | Mar 1, 1982 | SESE |
| K781750 | MIRROR WARMER | Arleton Technical Products, Inc. | Jan 17, 1979 | SESE |
| K770054 | MIRROR, NASO-PHARYNX | Welch Allyn, Inc. | Jan 18, 1977 | SESE |
| K770053 | MIRROR, LARYNGEAL | Welch Allyn, Inc. | Jan 18, 1977 | SESE |
Top Applicants
- Welch Allyn, Inc. — 2 clearances
- Treace Medical, Inc. — 2 clearances
- Kelleher Corp. — 2 clearances
- Microtek Medical, Inc. — 1 clearance
- Jedmed Instrument Co. — 1 clearance
