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510(k) K161101

PolypVac Microdebrider (3.3mm and 4.0mm) by Laurimed, LLC — Product Code ERL

K161101 is an FDA 510(k) premarket notification submitted by Laurimed, LLC for the device "PolypVac Microdebrider (3.3mm and 4.0mm)". The FDA issued a decision of Substantially Equivalent on June 22, 2016. 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. Laurimed, LLC has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2016
Date Received
April 19, 2016
Clearance Type
Special
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 Laurimed, LLC

  • K163247 — 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider (March 9, 2017)
  • K133133 — LAURIMED POLYPVAC MICRODEBRIDER (December 23, 2013)
  • K091818 — LAURIMED SPINAL INJECTION SYSTEM (September 23, 2009)
  • K090815 — PERCUTANEOUS DISCECTOMY SYSTEM (May 21, 2009)
  • K083909 — SPINAL INJECTION SYSTEM (March 18, 2009)
  • K082194 — LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 (August 28, 2008)
  • K080140 — LAURIMED SPINAL INJECTION SYSTEM (May 9, 2008)

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