TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT— 510(k) K963246

Name: FDA 510(k) clearance K963246
Creator: U.S. Food and Drug Administration
Published: 1996-09-23

Substantially Equivalent

Medtronic Xomed

FDA 510(k) clearance K963246 for TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT, Substantially Equivalent on 1996-09-23. Applicant: Medtronic Xomed. Device class: 2.

Clearance details

Applicant: Medtronic Xomed
Product code: Code ERL
Device class: Class 2
Regulation: 21 CFR 874.4250
Advisory panel: Ear, Nose, Throat
Date received: 1996-08-19
Decision date: 1996-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ERL

view all

K243280 — Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)2025-07-03
K233958 — hekaDrill2024-03-14
K221184 — ORiGO System2022-11-02
K213221 — AMADEO, M-UK1015 (incl. attachments and accessories)2022-05-26
K212650 — Celeris, Disposable Sinus Debrider2022-01-19

More clearances from Medtronic Xomed

view all

K202623 — Novapak Nasal Sinus Packing and Stent2020-12-08
K122434 — MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL2012-10-31
K031510 — NIM-SPINE2003-06-18
K002972 — MEROGEL CONTROL GEL ENT SURGICAL DRESSING2000-12-15
K002224 — XPS 3000 SYSTEM2000-12-04

Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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