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510(k) K821486

MICRO DRILLS by Spire Medical, Inc. — Product Code GFG

K821486 is an FDA 510(k) premarket notification submitted by Spire Medical, Inc. for the device "MICRO DRILLS". The FDA issued a decision of Substantially Equivalent on June 9, 1982. The device falls under product code GFG (Bit, Surgical), a Class I device regulated under 21 CFR 878.4820. Spire Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1982
Date Received
May 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bit, Surgical
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Spire Medical, Inc.

  • K821487 — MICRO-SURGICAL POWER INSTRUMENT SYS. (July 2, 1982)
  • K821485 — DERMABRADERS (June 10, 1982)
  • K802503 — MICRO-SUGICAL POWER INSTRUMENT SYSTEM (October 31, 1980)
  • K802463 — MICRO-SURGICAL POWER INSTRUMENT SYSTEM (October 31, 1980)

Other clearances for product code GFG

  • K935225 — MITEK MODULAR DRILL BIT (April 7, 1994)
  • K821127 — KEY DRILL (June 3, 1982)

FDA data resources