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510(k) K890195

JAMES SURGICAL SYSTEM J1000 by O.R. Specialties, Inc. — Product Code HQE

K890195 is an FDA 510(k) premarket notification submitted by O.R. Specialties, Inc. for the device "JAMES SURGICAL SYSTEM J1000". The FDA issued a decision of Substantially Equivalent on August 3, 1989. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. O.R. Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1989
Date Received
January 18, 1989
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 O.R. Specialties, Inc.

  • K942607 — LAPAROSCOPIC SCISSORS (DISPOSABLE) (July 6, 1994)
  • K923630 — PHACO NEEDLES 1000-R & 1000-O NEEDLES (April 6, 1994)
  • K925671 — DISPOSABLE SCLERAL PLUGS (August 2, 1993)
  • K923887 — JACK'S VENT TUBES (February 19, 1993)
  • K923774 — DISPOSABLE ENDOILLUMINATOR (October 19, 1992)
  • K922355 — POLLY'S VITREOUS SCISSORS J-225-S (August 18, 1992)
  • K922180 — LEWICKY O.R.S. TUBING (July 2, 1992)
  • K914038 — POLLY'S CUTTER J-225 (December 9, 1991)
  • K911932 — J105 JAMES SURGICAL SYSTEM I/A PACK (August 26, 1991)
  • K890825 — JUMPER PACK #203 (May 26, 1989)

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