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510(k) K802503

MICRO-SUGICAL POWER INSTRUMENT SYSTEM by Spire Medical, Inc. — Product Code EQJ

K802503 is an FDA 510(k) premarket notification submitted by Spire Medical, Inc. for the device "MICRO-SUGICAL POWER INSTRUMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. Spire Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Ear, Nose And Throat
Device Class
Class I
Regulation Number
874.4140
Review Panel
EN
Submission Type

Other clearances by Spire Medical, Inc.

  • K821487 — MICRO-SURGICAL POWER INSTRUMENT SYS. (July 2, 1982)
  • K821485 — DERMABRADERS (June 10, 1982)
  • K821486 — MICRO DRILLS (June 9, 1982)
  • K802463 — MICRO-SURGICAL POWER INSTRUMENT SYSTEM (October 31, 1980)

Other clearances for product code EQJ

  • K161514 — Precision Thin Reciprocating Blade, 0.010in. (January 17, 2017)
  • K041985 — XPS CURVED BUR (August 12, 2004)
  • K974232 — ESSENTIAL SHAVER SYSTEM (January 12, 1998)
  • K960853 — ACE SYSTEM (April 3, 1996)
  • K955704 — TREBAY MICRODEBRIDER SYSTEM (January 30, 1996)
  • K955294 — SOF - ABRASION BUR (December 22, 1995)
  • K954912 — TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (December 6, 1995)
  • K953370 — KARL STORZ ENT SHAVER (September 6, 1995)
  • K950337 — KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL (August 23, 1995)
  • K952609 — REDI DRILL DRILL SYSTEM (July 31, 1995)

FDA data resources