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510(k) K020594

DIEGO POWERED DISSECTOR AND DRILL SYSTEM by Gyrus Ent LLC — Product Code ERL

K020594 is an FDA 510(k) premarket notification submitted by Gyrus Ent LLC for the device "DIEGO POWERED DISSECTOR AND DRILL SYSTEM". The FDA issued a decision of Substantially Equivalent on March 8, 2002. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. Gyrus Ent LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2002
Date Received
February 22, 2002
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 Ent LLC

  • K040996 — RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING (August 20, 2004)
  • K034004 — DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE (March 3, 2004)
  • K033089 — HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM (February 5, 2004)
  • K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS (November 24, 2003)
  • K030343 — DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING IN (May 2, 2003)
  • K021595 — GYRUS ENT NERVE STIMULATOR (October 24, 2002)
  • K021777 — GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND P (August 26, 2002)
  • K020778 — GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 (May 28, 2002)
  • K020067 — GYRUS ENT SOMNOPLASTY GENERATOR (April 4, 2002)
  • K003214 — SMITH & NEPHEW PISTONS (October 31, 2000)

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)

FDA data resources