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510(k) K842820

ARTHROSCOPY KNIVES by Medtech Industries, Inc. — Product Code HTS

K842820 is an FDA 510(k) premarket notification submitted by Medtech Industries, Inc. for the device "ARTHROSCOPY KNIVES". The FDA issued a decision of Substantially Equivalent on August 14, 1984. The device falls under product code HTS (Knife, Orthopedic), a Class I device regulated under 21 CFR 888.4540. Medtech Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1984
Date Received
July 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Medtech Industries, Inc.

  • K910451 — CARD GUARD, MODEL CG-2000A (June 10, 1991)
  • K910450 — CARD GUARD-3000 ECG TELEPHONE ADAPTER (May 7, 1991)
  • K842819 — HOOK PUNCH FORCEPS FOR ARTHROSCOPY (August 14, 1984)

Other clearances for product code HTS

  • K930507 — CUSTOM ORTHOPAEDIC TRAYS (PACKS) (February 22, 1994)
  • K933921 — ACUFLEX DISPOSABLE KNIVES (January 26, 1994)
  • K882525 — SPINAL MICROKNIFE (September 22, 1988)
  • K873714 — BANANA KNIFE, DISPOSABLE #TM-1612 (November 2, 1987)
  • K873713 — TRIANGULAR KNIFE, DISPOSABLE #TM-1611 (November 2, 1987)
  • K873711 — RETROGRADE KNIFE, DISPOSABLE #TM-1613 (November 2, 1987)
  • K873712 — STANDARD KNIFE, DISPOSABLE #TM-1610 (October 15, 1987)
  • K771851 — ARTHROSCOPE OPERATIVE KNIFE SET (October 27, 1977)

FDA data resources