Home / 510(k) Clearances / K884076

510(k) K884076

SUREBREATH DOME by Ipax, Inc. — Product Code GAD

K884076 is an FDA 510(k) premarket notification submitted by Ipax, Inc. for the device "SUREBREATH DOME". The FDA issued a decision of Substantially Equivalent on October 7, 1988. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Ipax, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1988
Date Received
September 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ipax, Inc.

  • K200893 — ProntoPump Sterile Tube Set (May 4, 2021)
  • K971242 — BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) (December 17, 1997)
  • K971245 — BLINK EXTERNAL EYELID WEIGHT (June 20, 1997)
  • K915158 — SUREBREATH DOME, E-Z BREATHER (February 12, 1992)
  • K915118 — PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE (December 27, 1991)
  • K914172 — KPE 230 AM (October 25, 1991)
  • K914221 — KPE 220 TS, NONSTERILE (October 25, 1991)
  • K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (September 4, 1987)
  • K870770 — TIMLEINE(TM) VENIPUNCTURE SYSTEM (April 23, 1987)
  • K864726 — I/A/KPE TIP (January 20, 1987)

Other clearances for product code GAD

  • K152538 — JRP Wound Spreader (April 13, 2016)
  • K151104 — OTELO LL (January 6, 2016)
  • K132645 — THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES (October 4, 2013)
  • K071775 — DASH (August 7, 2007)
  • K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (April 26, 2005)
  • K043602 — QUADRANT RETRACTOR SYSTEM (February 23, 2005)
  • K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM (May 17, 2000)
  • K980588 — CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (August 18, 1998)
  • K963006 — SCION SAPHENOUS VEIN HARVESTING SYSTEM (September 20, 1996)
  • K943875 — VILLALTA RETRACTOR (November 9, 1994)

FDA data resources