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510(k) K021811

UNIDRIVE II PLUS DISPOSABLE TUBING SET by Mtp Medical Technical Promotion GmbH — Product Code ERL

K021811 is an FDA 510(k) premarket notification submitted by Mtp Medical Technical Promotion GmbH for the device "UNIDRIVE II PLUS DISPOSABLE TUBING SET". The FDA issued a decision of Substantially Equivalent on June 19, 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. Mtp Medical Technical Promotion GmbH has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2002
Date Received
June 3, 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 Mtp Medical Technical Promotion GmbH

  • K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (July 31, 2009)
  • K020599 — MTP CLEARVISION DISPOSABLE TUBING SET (March 13, 2002)
  • K011360 — MTP LAPAROMAT DISPOSABLE TUBING SET (July 19, 2001)
  • K000337 — MTP DISPOSABLE TROCAR VALVES (April 12, 2000)
  • K994066 — MTP DISPOSABLE TROCARS (January 20, 2000)
  • K990912 — MTP EXTRACTION BAG (June 9, 1999)
  • K990909 — MTP UROPUMP DISPOSABLE TUBING SET (June 9, 1999)
  • K990911 — MTP ARTHROPUMP DISPOSABLE TUBING SET (June 3, 1999)
  • K990910 — MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS (June 3, 1999)

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