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510(k) K897181

L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE by Intl. Medical Marketing, Inc. — Product Code FPD

K897181 is an FDA 510(k) premarket notification submitted by Intl. Medical Marketing, Inc. for the device "L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE". The FDA issued a decision of Substantially Equivalent (with conditions) on March 27, 1990. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Intl. Medical Marketing, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
March 27, 1990
Date Received
December 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Intl. Medical Marketing, Inc.

  • K895824 — L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET (March 13, 1990)
  • K896621 — L.T.C. REPLACEMENT GASTROSTOMY TUBE (March 13, 1990)
  • K895616 — L.T.C. FEEDING TUBE (October 24, 1989)
  • K895957 — L.T.C. 1000 URINARY DRAINAGE BAG (October 24, 1989)

Other clearances for product code FPD

  • K243361 — Nutrifit (December 19, 2024)
  • K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (January 18, 2019)
  • K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (October 23, 2013)
  • K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (March 6, 2013)
  • K121105 — NUTRISAFE 2 FEEDING TUBE (December 18, 2012)
  • K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (October 13, 2011)
  • K110853 — VR MEDICAL ENTERAL ORAL SYRINGE (May 13, 2011)
  • K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (December 13, 2010)
  • K101214 — GUARDIAN CONNECTION (July 23, 2010)
  • K100099 — ORAL/ENTERAL SYRINGES (June 14, 2010)

FDA data resources