Product code KTR— Ear, Nose, Throat

“If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”

FDA has cleared 4 devices under product code KTR between 1979 and 1993, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19931 clearance
• 19822 clearances
• 19791 clearance

• Sherwood Medical Co.2 clearances
• Kelleher Corp.1 clearance
• Ballard Medical Products1 clearance

• K923487 — BAL CATHBallard Medical Products·1993-07-30
• K822255 — RIGID SUCTION TIPSKelleher Corp.·1982-08-25
• K820572 — ARGYLE DELEE SUCTION CATHETER W/MUCOUSSherwood Medical Co.·1982-04-09
• K791327 — ARGYLE TAUSSIG CULTURE CATHETERSherwood Medical Co.·1979-08-22