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510(k) K853659

POWERED IRRIGATION FOR MICRO SURGICAL DRILL by Acumed Instruments Corp.

K853659 is an FDA 510(k) premarket notification submitted by Acumed Instruments Corp. for the device "POWERED IRRIGATION FOR MICRO SURGICAL DRILL". The FDA issued a decision of Substantially Equivalent on September 24, 1985. Acumed Instruments Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1985
Date Received
September 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Acumed Instruments Corp.

  • K863627 — MICRO SURGICAL DRILL SYSTEM (October 2, 1986)
  • K853660 — MICRO SURGICAL DRILL SYSTEM (September 24, 1985)
  • K853658 — BURS FOR MICRO SURGICAL DRILL SYSTEM (September 24, 1985)
  • K791891 — ACU-MED RED MISER HEMOTHORAX BLOOD COLL. (December 5, 1979)
  • K791399 — ACU-ALERT (October 11, 1979)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)
  • K790901 — I.V. TUBING ORGANIZER (June 27, 1979)

FDA data resources