Home / 510(k) Clearances / K933596

510(k) K933596

GASTRIC, CATHETER, IRRIGATION & ASPIRATION by Polamedco, Inc. — Product Code BSS

K933596 is an FDA 510(k) premarket notification submitted by Polamedco, Inc. for the device "GASTRIC, CATHETER, IRRIGATION & ASPIRATION". The FDA issued a decision of Substantially Equivalent on February 13, 1995. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980. Polamedco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1995
Date Received
July 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Polamedco, Inc.

  • K983000 — CRICOTHYROTOMY TUBE (October 27, 1999)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K953793 — INTROSCOPE (November 29, 1995)
  • K950713 — AIRGUIDE STYLETTE (May 17, 1995)
  • K950380 — FLEXTITIP STYLETTE (February 10, 1995)
  • K920900 — POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES (March 18, 1992)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K900457 — CUFFED LINDER NASOTRACHEAL AIRWAY (April 16, 1990)
  • K894516 — VISOSHIELD(TM), SURGICAL EYE PROTECTOR (September 12, 1989)
  • K881496 — LINDER NASOTRACHEAL AIRWAY (May 31, 1988)

Other clearances for product code BSS

  • K142483 — TurboSEAL Nasogastric Aspiration Tube (December 19, 2014)
  • K051480 — ENTERAL FEEDING TUBE (October 12, 2005)
  • K984629 — MOSS TUBES, INC. NASAL TUBE - MARK IV (March 2, 1999)
  • K961711 — ASPISAFE GASTRIC TUBE (June 11, 1997)
  • K930510 — RADIUS ENTERAL FEEDING TUBE (February 1, 1995)
  • K935688 — AN-10S ANDERSEN TUBE WITH STYLET (December 30, 1994)
  • K934348 — TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR (December 23, 1994)
  • K905573 — XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A (June 19, 1991)
  • K910479 — ARGYLE POLYURETHANE SALEM SUMP TUBE (April 19, 1991)
  • K894870 — WILTEK NASAL BILIARY DRAINAGE SET (December 21, 1989)

FDA data resources