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510(k) K022840

STEPHENS DISPOSABLE SCISSORS by Stephens Instruments — Product Code HNF

K022840 is an FDA 510(k) premarket notification submitted by Stephens Instruments for the device "STEPHENS DISPOSABLE SCISSORS". The FDA issued a decision of Substantially Equivalent on November 1, 2002. The device falls under product code HNF (Scissors, 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
Scissors, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Stephens Instruments

  • K022842 — STEPHENS DISPOSABLE HOOKS (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 HNF

  • K897093 — INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. (April 4, 1990)
  • K873099 — MANUAL OPHTHALMIC SURGICAL INSTRUMENTS (September 4, 1987)
  • K851768 — 13-550,13-560 WESCOTT SCOSSORS (EYE) (June 20, 1985)
  • K822151 — SURGICAL INSTRUMENTS REPRESENT. 4 CLASS (August 19, 1982)
  • K821290 — LITTAUER SCISSORS 5 1/2 (May 28, 1982)
  • K821286 — IRIS SCISSORS STRAIGHT 4 1/2 (May 28, 1982)
  • K811245 — OPHTHALMIC SCISSORS (July 31, 1981)
  • K770041 — SCISSORS, STRABISMUS, 4 CURVED (January 14, 1977)
  • K770040 — SCISSORS, STRABIMUS, 4 STRAIGHT (January 14, 1977)
  • K770019 — SCISSORS, IRIS (January 12, 1977)

FDA data resources