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510(k) K930205

ELECTRIC WIRE DRIVER, MODEL 2640E by Micro Surgical Instruments Corp. — Product Code HXJ

K930205 is an FDA 510(k) premarket notification submitted by Micro Surgical Instruments Corp. for the device "ELECTRIC WIRE DRIVER, MODEL 2640E". The FDA issued a decision of Substantially Equivalent on August 2, 1993. The device falls under product code HXJ (Staple Driver), a Class I device regulated under 21 CFR 888.4540. Micro Surgical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1993
Date Received
January 15, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple Driver
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
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)
  • K914998 — MICROAIRE(R) FACIAL BONE PLATING SYSTEM (June 2, 1992)
  • K915139 — MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE (February 5, 1992)
  • K914346 — DRILL MODULES MODELS 2116/2117 (November 27, 1991)
  • 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 HXJ

  • K964953 — IN-TAC BONE ANCHOR SYSTEM (February 13, 1997)
  • K962372 — UROTAC BONE ANCHOR INSERTER (August 19, 1996)
  • K834515 — FIXATION STAPLE KIT - DLIDE HAMMER (April 23, 1984)
  • K830255 — OSTEOTOMY BONE STAPLE (March 9, 1983)
  • K830456 — STAPLE INSERTER-EXTRACTOR FOR ARTHROS (March 9, 1983)

FDA data resources