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510(k) K913504

STORZ MICRO CUTTER 25 GAUGE PACK by Storz — Product Code HQE

K913504 is an FDA 510(k) premarket notification submitted by Storz for the device "STORZ MICRO CUTTER 25 GAUGE PACK". The FDA issued a decision of Substantially Equivalent on February 21, 1992. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Storz has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1992
Date Received
August 7, 1991
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 Storz

  • K960007 — STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (March 26, 1996)
  • K952151 — STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR C (March 4, 1996)
  • K954340 — STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE (December 14, 1995)
  • K930278 — STORZ COMPUSCAN AB (February 9, 1994)
  • K926512 — STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE (September 9, 1993)

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