Home / 510(k) Clearances / K011195

510(k) K011195

PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB by Surgin Surgical Instrumentation, Inc. — Product Code HNO

K011195 is an FDA 510(k) premarket notification submitted by Surgin Surgical Instrumentation, Inc. for the device "PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB". The FDA issued a decision of Substantially Equivalent on November 6, 2001. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Surgin Surgical Instrumentation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2001
Date Received
April 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

Other clearances by Surgin Surgical Instrumentation, Inc.

  • K082110 — DUAL SYRINGE HOLDER (June 17, 2009)
  • K033236 — PRIZM KERATOME BLADE, MODEL MK8512M2 (March 26, 2004)
  • K033182 — PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD (January 30, 2004)
  • K994015 — ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 (March 15, 2000)
  • K980849 — SURGIN KIT (July 9, 1998)
  • K954238 — SURGIN GENISIS HANDPIECE (December 8, 1995)
  • K950600 — VACUUM SURGE SUPRESSER (May 10, 1995)
  • K942945 — CASSETTE SYSTEM FOR STORZ (December 5, 1994)
  • K942944 — IRRIGATION/BIPOLAR SET (September 27, 1994)
  • K942897 — OPTHALMIC WIPE (August 5, 1994)

Other clearances for product code HNO

  • K173371 — VisuMax Femtosecond Laser (April 13, 2018)
  • K172994 — EPI K Console (October 26, 2017)
  • K072102 — EPIVISION SL SYSTEM (January 16, 2009)
  • K082043 — CARRIAZO-PENDULAR MICROKERATOME (August 1, 2008)
  • K062465 — ZYOPTIX XP EPI SEPARATOR SYSTEM (September 6, 2006)
  • K052891 — HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (March 23, 2006)
  • K051486 — NORWOOD ABBEY CENTURION SES EPIKERATOME (July 6, 2005)
  • K043183 — EPI-K (March 25, 2005)
  • K043150 — AMADEUS II EPIKERATOME (January 31, 2005)
  • K042083 — MODIFICATION TO VISITOME 20-10 MICROKERATOME (November 16, 2004)

FDA data resources