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510(k) K011191

MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES by Medtronic Xomed, Inc. — Product Code HOZ

K011191 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES". The FDA issued a decision of Substantially Equivalent on June 26, 2001. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Medtronic Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2001
Date Received
April 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type

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  • K202623 — Novapak Nasal Sinus Packing and Stent (December 8, 2020)
  • K200759 — NIM Vital, Nerve Integrity Monitor (October 28, 2020)
  • K173855 — Sharpsite AC Rigid Endsocope (April 20, 2018)
  • K152121 — NuVent EM Sinus Dilation System (December 1, 2015)
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Other clearances for product code HOZ

  • K132796 — SUNTOUCH EYE SPEAR (October 30, 2013)
  • K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (October 29, 2013)
  • K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (October 23, 2009)
  • K082460 — CENEFOM PVA SURGICAL SPEAR (December 15, 2008)
  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K003842 — PRESCOTT'S SURGICAL SPEAR (April 13, 2001)
  • K002279 — ML EYE SPEAR, MODEL ML 27 ES (August 18, 2000)
  • K993883 — M-PACT CORNEAL LIGHT SHIELD (December 21, 1999)
  • K990671 — DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIP (May 10, 1999)
  • K990749 — SOF-SUCTION FLUID EVACUATION SYSTEM (April 2, 1999)

FDA data resources