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510(k) K864292

DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY by Eye-Ko, Inc. — Product Code HNQ

K864292 is an FDA 510(k) premarket notification submitted by Eye-Ko, Inc. for the device "DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY". The FDA issued a decision of Substantially Equivalent on December 29, 1986. The device falls under product code HNQ (Hook, Ophthalmic), a Class I device regulated under 21 CFR 886.4350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1986
Date Received
October 31, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hook, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances for product code HNQ

  • K030471 — OPHTEC ENCLAVATION NEEDLE (April 17, 2003)
  • K022842 — STEPHENS DISPOSABLE HOOKS (November 1, 2002)
  • K874991 — PRISMA DISPOSABLE IRRIGATING IRIS HOOK (April 13, 1988)
  • K870440 — LOOK LENS LOOPS (February 20, 1987)
  • K863988 — THORTON TITANIUM HOOK ANGLED RIGHT (October 31, 1986)
  • K801469 — BONN MICRO IRIS HOOK (NON-STERILE) #7613 (July 28, 1980)
  • K791985 — HOOKS #'S 7600,7602,7603,7616 (October 4, 1979)
  • K770103 — HOOK, IRIS, SHEPARD U-SHAPED (January 25, 1977)
  • K770098 — HOOK, IRIS, HERSHMAN (January 24, 1977)

FDA data resources