Home / 510(k) Clearances / K954715

510(k) K954715

MICRO-PLANER HANDPIECE by Trebay Medical Corp. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1995
Date Received
October 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

Other clearances by Trebay Medical Corp.

  • K955704 — TREBAY MICRODEBRIDER SYSTEM (January 30, 1996)
  • K955294 — SOF - ABRASION BUR (December 22, 1995)
  • K955560 — TREBAY SCOPE IRRIGATED CLEARING SLEEVE (December 22, 1995)
  • K955447 — TYMPANOSTOMY TUBE (December 21, 1995)
  • K954912 — TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (December 6, 1995)
  • K954795 — AT2 & DOYLE STYLE (C-FLEX) VENT TUBES (November 15, 1995)
  • K954796 — MICRO-INGRESSOR HANDIPIECE (November 6, 1995)
  • K954518 — TREBAY TOTAL RECTANGULAR HEAD (October 27, 1995)
  • K954517 — TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT (October 27, 1995)
  • K952226 — C-FLEX SEPTAL SPLINTS (August 11, 1995)

Other clearances for product code ERL

  • K243280 — Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro (July 3, 2025)
  • K233958 — hekaDrill (March 14, 2024)
  • K221184 — ORiGO System (November 2, 2022)
  • K213221 — AMADEO, M-UK1015 (incl. attachments and accessories) (May 26, 2022)
  • K212650 — Celeris, Disposable Sinus Debrider (January 19, 2022)
  • K211490 — Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Numb (June 9, 2021)
  • K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver (October 22, 2020)
  • K190715 — EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter (December 13, 2019)
  • K180063 — OCM-G1 Attachment (March 27, 2018)
  • K171840 — Stryker Consolidated Operating Room Equipment (CORE) 2 Console (September 15, 2017)