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510(k) K882793

PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE by Pmt Corp. — Product Code GAF

K882793 is an FDA 510(k) premarket notification submitted by Pmt Corp. for the device "PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code GAF (Spatula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Pmt Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1988
Date Received
July 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spatula, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Pmt Corp.

  • K122376 — PMT TRUSCAN SURFACE ELECTRODE (December 19, 2012)
  • K090733 — PMT HALO SYSTEM (July 28, 2009)
  • K082474 — PMT SUBDURAL CORTICAL ELECTRODES (May 8, 2009)
  • K042901 — ENDOMARK STERILE INDIA INK (March 16, 2005)
  • K033730 — PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES (August 3, 2004)
  • K972597 — PMT NEW BEGINNINGS GELSHAPES & AMEND (October 1, 1997)
  • K970418 — PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) (April 29, 1997)
  • K964224 — STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTR (March 19, 1997)
  • K935560 — PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) (November 7, 1994)
  • K933079 — ELECTROCAUTERY SYSTEM MODEL 1980 (February 22, 1994)

Other clearances for product code GAF

  • K023688 — LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER (January 30, 2003)
  • K935357 — SNAP RECIPROCATING SAW (January 28, 1994)
  • K890374 — ABDOMINAL SPATULA (February 3, 1989)
  • K822108 — CEMENT-PICK (August 11, 1982)

FDA data resources