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510(k) K851339

PRECISION HARVEST & INLAY INSTRUMENT SET by Concept, Inc. — Product Code HWK

K851339 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "PRECISION HARVEST & INLAY INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on July 2, 1985. The device falls under product code HWK (Trephine), a Class I device regulated under 21 CFR 888.4540. Concept, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1985
Date Received
April 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trephine
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Concept, Inc.

  • K912640 — CONCEPT ENDOSTEAL FIXATION DEVICE (May 1, 1992)
  • K912957 — CONCEPT MICROMILL (October 4, 1991)
  • K896648 — CONCEPT UNICOMPARTMENTAL KNEE SYSTEM (June 5, 1990)
  • K894929 — STAPLE FIXATION SYSTEM (August 30, 1989)
  • K892376 — INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) (August 1, 1989)
  • K891109 — PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE (May 8, 1989)
  • K881954 — CONCEPT POWER SYSTEM (November 9, 1988)
  • K884255 — CONCEPT CCT-5200, THERMAL THERAPY SYSTEM (November 8, 1988)
  • K882121 — C-FLO SUCTION TUBE (June 20, 1988)
  • K880414 — TENDON HARVESTER (March 25, 1988)

FDA data resources