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510(k) K903036

P.R.G. GUIDEWIRE PLACEMENT SYSTEM by Applied Medical Technologies — Product Code KGC

K903036 is an FDA 510(k) premarket notification submitted by Applied Medical Technologies for the device "P.R.G. GUIDEWIRE PLACEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent (with conditions) on November 19, 1990. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
November 19, 1990
Date Received
July 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Gastro-Enterostomy
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Applied Medical Technologies

  • K971434 — A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE (August 17, 1998)
  • K972478 — PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES (February 9, 1998)
  • K973893 — AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON M (December 19, 1997)
  • K971757 — LOW PROFILE FEEDING SET ACCESSORY (November 7, 1997)
  • K971758 — CAUTERIZATION SMOKE EVACUATOR (July 21, 1997)
  • K961345 — DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE (September 17, 1996)
  • K960232 — ENDOSCOPIC ACCESS DEVICE (March 21, 1996)
  • K945618 — GASTROINTESTINAL TUBES & ACCESSORIES (October 12, 1995)
  • K946140 — PRG BUTTON (August 28, 1995)
  • K923488 — GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY (July 20, 1995)

Other clearances for product code KGC

  • K242211 — PUMA-G Pediatric System (April 29, 2025)
  • K223916 — PUMA-G System (March 29, 2023)
  • K193612 — AMT Suture Delivery System (March 12, 2020)
  • K191844 — Fidmi Low Profile Enteral Feeding Device (September 30, 2019)
  • K182832 — Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set (June 26, 2019)
  • K183057 — PUMA-G System (April 10, 2019)
  • K170323 — Entuit Start Initial Placement Gastrostomy Set (September 14, 2017)
  • K120587 — AMT T-FASTENER ANCHOR KIT (May 25, 2012)
  • K093312 — KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL A (December 8, 2009)
  • K073718 — MEDLINE GASTROSTOMY TUBE (March 19, 2008)

FDA data resources