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510(k) K873097

PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS by Ipax, Inc. — Product Code GBQ

K873097 is an FDA 510(k) premarket notification submitted by Ipax, Inc. for the device "PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS". The FDA issued a decision of Substantially Equivalent on September 4, 1987. The device falls under product code GBQ (Catheter, Continuous Irrigation), a Class I device regulated under 21 CFR 878.4200. Ipax, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1987
Date Received
July 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Irrigation
Device Class
Class I
Regulation Number
878.4200
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)
  • K914221 — KPE 220 TS, NONSTERILE (October 25, 1991)
  • K914172 — KPE 230 AM (October 25, 1991)
  • K884076 — SUREBREATH DOME (October 7, 1988)
  • K870770 — TIMLEINE(TM) VENIPUNCTURE SYSTEM (April 23, 1987)
  • K864726 — I/A/KPE TIP (January 20, 1987)

Other clearances for product code GBQ

  • K941356 — MICROFLOW IRRIGATION SYSTEM (May 19, 1994)
  • K921464 — CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT (May 5, 1992)
  • K882647 — GESCO CATHETERIZATION TRAY (September 9, 1988)
  • K874596 — PERFORATED SOAKING TUBE (December 2, 1987)
  • K872787 — MODIFIED CURLCATH (August 4, 1987)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)
  • K771732 — THORNTON ANTERIOR CHAMBER IRRIGATOR (September 28, 1977)

FDA data resources