[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.4420]

[Page 346]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874--EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                       Subpart E--Surgical Devices
 
Sec. 874.4420  Ear, nose, and throat manual surgical instrument.

    (a) 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 tub; 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 tub; 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.
    (b) Classification Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9.

[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 
FR 2316, Jan. 14, 2000]