MICRO-PLANER HANDPIECE— 510(k) K954715

Name: FDA 510(k) clearance K954715
Creator: U.S. Food and Drug Administration
Published: 1995-10-27

Substantially Equivalent

Trebay Medical Corp.

FDA 510(k) clearance K954715 for MICRO-PLANER HANDPIECE, Substantially Equivalent on 1995-10-27. Applicant: Trebay Medical Corp.. Device class: 2.

Clearance details

Applicant: Trebay Medical Corp.
Product code: Code ERL
Device class: Class 2
Regulation: 21 CFR 874.4250
Advisory panel: Ear, Nose, Throat
Date received: 1995-10-12
Decision date: 1995-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, 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 Trebay Medical Corp.

view all

K955704 — TREBAY MICRODEBRIDER SYSTEM1996-01-30
K955294 — SOF - ABRASION BUR1995-12-22
K955560 — TREBAY SCOPE IRRIGATED CLEARING SLEEVE1995-12-22
K955447 — TYMPANOSTOMY TUBE1995-12-21
K954912 — TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)1995-12-06

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.