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510(k) K921946

TUM-E-VAC BITE BLOCK by Ethox Corp. — Product Code JXL

K921946 is an FDA 510(k) premarket notification submitted by Ethox Corp. for the device "TUM-E-VAC BITE BLOCK". The FDA issued a decision of Substantially Equivalent on December 9, 1992. The device falls under product code JXL (Block, Bite), a Class II device regulated under 21 CFR 882.5070. Ethox Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1992
Date Received
April 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Bite
Device Class
Class II
Regulation Number
882.5070
Review Panel
NE
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)
  • K962850 — TUM-E-VAC (February 21, 1997)
  • K935633 — NO-MES (September 30, 1994)
  • 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 JXL

  • K221469 — PATI (Protector Against Tongue Injury) (February 22, 2023)
  • K201309 — ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (June 4, 2021)
  • K172978 — SurgeoBite (December 22, 2017)
  • K150518 — Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and To (June 29, 2015)
  • K050188 — EPIGUARD (April 27, 2005)
  • K992269 — VENTIL-A ORAL PROTECTOR (October 25, 1999)
  • K960663 — UNIVERSAL BITE BLOCK (May 17, 1996)
  • K954352 — BITE BLOCK (January 25, 1996)
  • K941856 — PREMIER PROMAX BITE GUARD (April 5, 1995)
  • K924333 — THE DAVIS DISPOSABLE PROTECTIVE SPLINT (April 23, 1993)

FDA data resources