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510(k) K962850

TUM-E-VAC by Ethox Corp. — Product Code KDH

K962850 is an FDA 510(k) premarket notification submitted by Ethox Corp. for the device "TUM-E-VAC". The FDA issued a decision of Substantially Equivalent on February 21, 1997. The device falls under product code KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration), a Class II device regulated under 21 CFR 876.5980. Ethox Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1997
Date Received
July 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Ethox Corp.

  • K040286 — ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS (March 15, 2004)
  • K031195 — CUF-COVER (TM) (October 10, 2003)
  • K935633 — NO-MES (September 30, 1994)
  • K921946 — TUM-E-VAC BITE BLOCK (December 9, 1992)
  • K885220 — PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (September 25, 1989)
  • K894927 — SURGI SQUEEZ (September 11, 1989)
  • K883977 — SURGI-CUF STERILE/NON-STERILE DISPOSABLE (February 10, 1989)
  • K860599 — ETHOX LAVAGE TUBE (March 11, 1986)
  • K844988 — ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. (April 4, 1985)
  • K841512 — ETHOX RELIA-FLO 2001 ENTERAL FEED (May 21, 1984)

Other clearances for product code KDH

  • K983624 — GILTECH PLUS CONNECTING TUBE SET (March 18, 1999)
  • K981286 — SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS (June 19, 1998)
  • K971259 — COMBIPORT FLUID LAVAGE DEVICE (October 27, 1997)
  • K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (July 5, 1995)
  • K923497 — FLUSHING IRRIGATION SET (March 21, 1994)
  • K920527 — TRI-MED QUICK-STEP GASTRIC LAVAGE KIT (September 4, 1992)
  • K920619 — TRI-MED GASTRIC LAVAGE SYSTEM (September 4, 1992)
  • K914908 — QUICVAGE PLUS (April 13, 1992)
  • K914907 — QUICVAGE (January 24, 1992)
  • K911788 — ECONOVAGE R (July 26, 1991)

FDA data resources