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510(k) K030471

OPHTEC ENCLAVATION NEEDLE by Ophtec, USA — Product Code HNQ

K030471 is an FDA 510(k) premarket notification submitted by Ophtec, USA for the device "OPHTEC ENCLAVATION NEEDLE". The FDA issued a decision of Substantially Equivalent on April 17, 2003. 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
April 17, 2003
Date Received
February 12, 2003
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

  • K022842 — STEPHENS DISPOSABLE HOOKS (November 1, 2002)
  • K874991 — PRISMA DISPOSABLE IRRIGATING IRIS HOOK (April 13, 1988)
  • K870440 — LOOK LENS LOOPS (February 20, 1987)
  • K864292 — DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY (December 29, 1986)
  • 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