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510(k) K022842

STEPHENS DISPOSABLE HOOKS by Stephens Instruments — Product Code HNQ

K022842 is an FDA 510(k) premarket notification submitted by Stephens Instruments for the device "STEPHENS DISPOSABLE HOOKS". The FDA issued a decision of Substantially Equivalent on November 1, 2002. The device falls under product code HNQ (Hook, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Stephens Instruments has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2002
Date Received
August 27, 2002
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 by Stephens Instruments

  • K022840 — STEPHENS DISPOSABLE SCISSORS (November 1, 2002)
  • K022835 — STEPHENS DISPOSABLE FORCEPS (November 1, 2002)
  • K022836 — STEPHENS DISPOSABLE SPECULUM (November 1, 2002)
  • K022843 — GAYHEART CORNEAL EXCISION DEVICE (November 1, 2002)

Other clearances for product code HNQ

  • K030471 — OPHTEC ENCLAVATION NEEDLE (April 17, 2003)
  • 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