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510(k) K042901

ENDOMARK STERILE INDIA INK by Pmt Corp. — Product Code NBG

K042901 is an FDA 510(k) premarket notification submitted by Pmt Corp. for the device "ENDOMARK STERILE INDIA INK". The FDA issued a decision of Substantially Equivalent on March 16, 2005. The device falls under product code NBG (Marker, Colon), a Class II device regulated under 21 CFR 876.1500. Pmt Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2005
Date Received
October 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Colon
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
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)
  • 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)
  • K935499 — PMT SILICONE SHEETING (February 10, 1994)

Other clearances for product code NBG

  • K993951 — SPOT ENDOSCOPIC MARKER (February 18, 2000)

FDA data resources