Product code ESZ— Ear, Nose, Throat

FDA has cleared 4 devices under product code ESZ between 1984 and 1998, filed by 4 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.

• 19981 clearance
• 19951 clearance
• 19901 clearance
• 19841 clearance

• Trebay Medical Corp.1 clearance
• Treace Medical, Inc.1 clearance
• Hood Laboratories1 clearance
• Exmoor Plastics , Ltd.1 clearance

• K974224 — ENDOLYMPHATIC SAC TO MASTOID T-SHUNTExmoor Plastics , Ltd.·1998-01-27
• K952227 — C-FLEX ENDOLYMPHATIC SHUNTTrebay Medical Corp.·1995-06-16
• K897049 — GIBSON ENDOLYMPHATIC SHUNTHood Laboratories·1990-03-16
• K834094 — AUSTIN ENDOLYMPH DISPERSMENT SHUNTTreace Medical, Inc.·1984-09-20