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510(k) K942897

OPTHALMIC WIPE by Surgin Surgical Instrumentation, Inc. — Product Code HQZ

K942897 is an FDA 510(k) premarket notification submitted by Surgin Surgical Instrumentation, Inc. for the device "OPTHALMIC WIPE". The FDA issued a decision of Substantially Equivalent on Aug 5, 1994. The device falls under product code HQZ (Frame, Spectacle), a Class I device regulated under 21 CFR 886.5842. Surgin Surgical Instrumentation, Inc. has 22 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 5, 1994
Date Received
Jun 20, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Frame, Spectacle
Device Class
Class I
Regulation Number
886.5842
Review Panel
OP
Submission Type
510(k) Exempt

Other clearances by Surgin Surgical Instrumentation, Inc.

  • K082110 — DUAL SYRINGE HOLDER (Jun 17, 2009)
  • K033236 — PRIZM KERATOME BLADE, MODEL MK8512M2 (Mar 26, 2004)
  • K033182 — PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD (Jan 30, 2004)
  • K011195 — PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB /… (Nov 6, 2001)
  • K994015 — ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 (Mar 15, 2000)
  • K980849 — SURGIN KIT (Jul 9, 1998)
  • K954238 — SURGIN GENISIS HANDPIECE (Dec 8, 1995)
  • K950600 — VACUUM SURGE SUPRESSER (May 10, 1995)
  • K942945 — CASSETTE SYSTEM FOR STORZ (Dec 5, 1994)
  • K942944 — IRRIGATION/BIPOLAR SET (Sep 27, 1994)

Other clearances for product code HQZ

  • K952597 — VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN… (Sep 12, 1995)
  • K944313 — SPECTACLE FRAME (Mar 28, 1995)
  • K945176 — SPECTACLE FRAME OR EYEGLASS FRAMES (Dec 15, 1994)
  • K945392 — SPECTACLE FRAME (Dec 15, 1994)
  • K945770 — OPTICAL FRAMES (Dec 15, 1994)
  • K945350 — FRAME, SPECTACLES (Dec 13, 1994)
  • K945342 — MAG-1 SPECTACLE FRAME (Nov 28, 1994)
  • K945450 — FRAME, SPECTACLE (Nov 22, 1994)
  • K945340 — SPECTACLE FRAMES OR EYEGLASS FRAMES (Nov 22, 1994)
  • K945123 — ARISTAR EYEWEAR, ESPRIT EYEWEAR (Nov 22, 1994)

FDA data resources