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510(k) K860014

SYSTEMS PLUS by United Surgical Corp. — Product Code HQE

K860014 is an FDA 510(k) premarket notification submitted by United Surgical Corp. for the device "SYSTEMS PLUS". The FDA issued a decision of Substantially Equivalent on March 5, 1986. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. United Surgical Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1986
Date Received
January 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by United Surgical Corp.

  • K902150 — PIEZO HANDPIECE (July 5, 1990)
  • K870671 — PHACOTRON DAY PAK (April 6, 1987)
  • K870806 — NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 (March 26, 1987)
  • K870195 — UNITED SURGICAL CORP. CRYOPTIC PLUS (February 20, 1987)
  • K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS (February 20, 1987)
  • K830741 — PARAMETRIC STERILITY RELEASE OF AUTO (August 11, 1983)

Other clearances for product code HQE

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • K170183 — Cetus system, Cetus probe (September 27, 2017)
  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121675 — VERSAVIT (June 21, 2012)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)

FDA data resources