Home / 510(k) Clearances / K833961

510(k) K833961

I/A PLUS PAK SURGICAL SYSTEM by Ipax, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1984
Date Received
November 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
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)
  • K884076 — SUREBREATH DOME (October 7, 1988)
  • K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (September 4, 1987)
  • K870770 — TIMLEINE(TM) VENIPUNCTURE SYSTEM (April 23, 1987)

Other clearances for product code HQC

  • K250501 — System Sophi (November 14, 2025)
  • K243395 — MICOR 700 with Auto I/A (August 8, 2025)
  • K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-5062 (June 11, 2025)
  • K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (July 26, 2024)
  • K233398 — Faros Surgical System (June 27, 2024)
  • K233876 — UNITY VCS (8065000296); UNITY CS (8065000297) (June 21, 2024)
  • K232084 — Stellaris Elite vision enhancement system (February 26, 2024)
  • K233902 — Centurion™ Vision System (Active Sentry™) (8065753057) (January 10, 2024)
  • K230858 — QUATERA 700 (July 31, 2023)
  • K214028 — MICOR Lens Fragmentation System (September 9, 2022)