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510(k) K914346

DRILL MODULES MODELS 2116/2117 by Micro Surgical Instruments Corp. — Product Code ERL

K914346 is an FDA 510(k) premarket notification submitted by Micro Surgical Instruments Corp. for the device "DRILL MODULES MODELS 2116/2117". The FDA issued a decision of Substantially Equivalent on November 27, 1991. 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. Micro Surgical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1991
Date Received
September 27, 1991
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 Micro Surgical Instruments Corp.

  • K931395 — SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM (January 28, 1994)
  • K932492 — IMPLANTOLOGY MODULE, MODEL 2175 (October 5, 1993)
  • K930205 — ELECTRIC WIRE DRIVER, MODEL 2640E (August 2, 1993)
  • K914998 — MICROAIRE(R) FACIAL BONE PLATING SYSTEM (June 2, 1992)
  • K915139 — MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE (February 5, 1992)
  • K913369 — MICRO-AIRE MODEL 2060 (November 1, 1991)
  • K913266 — MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS (October 21, 1991)
  • K910175 — FIXATION DEVICES AND BONE PLATE (June 21, 1991)
  • K905383 — 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY (June 18, 1991)
  • K905207 — MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (January 22, 1991)

Other clearances for product code ERL

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  • 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