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510(k) K172978

SurgeoBite by Surgovations, LLC — Product Code JXL

K172978 is an FDA 510(k) premarket notification submitted by Surgovations, LLC for the device "SurgeoBite". The FDA issued a decision of Substantially Equivalent on December 22, 2017. The device falls under product code JXL (Block, Bite), a Class II device regulated under 21 CFR 882.5070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2017
Date Received
September 27, 2017
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 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)
  • 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)
  • K924304 — BITE BLOCK (April 6, 1993)

FDA data resources