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510(k) K841629

DRILL BIT by Plastafil, Inc. — Product Code HTW

K841629 is an FDA 510(k) premarket notification submitted by Plastafil, Inc. for the device "DRILL BIT". The FDA issued a decision of Substantially Equivalent on August 27, 1984. The device falls under product code HTW (Bit, Drill), a Class I device regulated under 21 CFR 888.4540. Plastafil, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1984
Date Received
April 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bit, Drill
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Plastafil, Inc.

  • K841620 — FRONT RADIUS CUTTER (September 20, 1984)
  • K841621 — BACK RADIUS CUTTER (September 20, 1984)
  • K841626 — PUNCH (August 27, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841617 — STROVER HOOK (August 27, 1984)
  • K841624 — PROBE (August 27, 1984)
  • K841625 — HOOK (August 27, 1984)
  • K841627 — MALLET (August 27, 1984)
  • K841628 — WIRE (July 23, 1984)
  • K841619 — DRILL GUIDE (July 11, 1984)

Other clearances for product code HTW

  • K151661 — Renovo Life Hard Carbon Coated Drill Bit (January 15, 2016)
  • K942906 — AGEE-WRISTJACK PRE-DRILL KIT (December 22, 1994)
  • K930339 — REAMER BIT (August 6, 1993)
  • K915692 — CANNULATED DRILL BIT (January 16, 1992)
  • K892903 — MITEK ANCHOR DRILL (October 6, 1989)
  • K870217 — FEMORAL CEMENT REMOVAL INSTRUMENTS (February 6, 1987)
  • K863147 — GLENOID DRILL (September 5, 1986)
  • K834229 — BONE PLUGGING TOOL (January 10, 1984)
  • K831712 — SURGICAL DRILL BITS (July 7, 1983)
  • K820226 — UNIVERSALL DRILL GUIDE (February 4, 1982)

FDA data resources