Product code JEL— Ear, Nose, Throat

PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS

Classification name: Curette, Biopsy, Bronchoscope (Rigid)
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Total cleared: 1
First cleared: 1994-02-22
Most recent: 1994-02-22

FDA classification definition

“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).”
— U.S. Food and Drug Administration, device classification record for product code JEL under 21 CFR 874.4680, via openFDA

Market context for product code JEL

FDA has cleared 1 device under product code JEL, all in 1994, filed by 1 applicant company. 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.

Top applicants under product code JEL

Applied Osteo Systems, Inc.1 clearance

Recent clearances under product code JEL

K932853 — PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINSApplied Osteo Systems, Inc.·1994-02-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.