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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 August 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1994
Date Received
June 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

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)
  • K011195 — PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511 (November 6, 2001)
  • 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)

Other clearances for product code HQZ

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

FDA data resources