Tracheotome

Device Code: 1597

Product Code(s): LJW

Device Classification Information

• Device Type ID: 1597
• Device Name: Tracheotome
• Regulation Description: Ear, Nose, And Throat Manual Surgical Instrument.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Ear, Nose, And Throat Devices Branch (ENTB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 874.4420 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: LJW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 1597
• Device: Tracheotome
• Product Code: LJW
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Ear, Nose, And Throat Manual Surgical Instrument.
• CFR Regulation Number: 874.4420 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Angiodynamics Inc. (Navilyst Medical Inc.)	II	Feb-03-2017

TPLC Last Update: 2019-04-02 19:56:19