Home / 510(k) Clearances / K152744

510(k) K152744

DIEGO ELITE DRILL by Gyrus Acmi, Inc. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2016
Date Received
September 23, 2015
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 Gyrus Acmi, Inc.

  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)
  • K233275 — RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-us (March 25, 2024)
  • K231327 — POWERSEAL Sealer and Divider (October 25, 2023)
  • K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperP (January 27, 2023)
  • K212650 — Celeris, Disposable Sinus Debrider (January 19, 2022)
  • K213831 — Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (January 4, 2022)
  • K211401 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed (June 3, 2021)
  • K181696 — ChitoZolve (November 30, 2018)
  • K180086 — Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter (March 8, 2018)
  • K171440 — Berkeley VC-10 Vacuum Curettage System (September 29, 2017)

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)