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510(k) K022843

GAYHEART CORNEAL EXCISION DEVICE by Stephens Instruments — Product Code HRH

K022843 is an FDA 510(k) premarket notification submitted by Stephens Instruments for the device "GAYHEART CORNEAL EXCISION DEVICE". The FDA issued a decision of Substantially Equivalent on November 1, 2002. The device falls under product code HRH (Trephine, Manual, 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
Trephine, Manual, 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)
  • K022840 — STEPHENS DISPOSABLE SCISSORS (November 1, 2002)
  • K022835 — STEPHENS DISPOSABLE FORCEPS (November 1, 2002)
  • K022836 — STEPHENS DISPOSABLE SPECULUM (November 1, 2002)

Other clearances for product code HRH

  • K931792 — ARTHROSCOPE (June 13, 1994)
  • K873918 — HEAD & CHIN RESTS (October 28, 1987)
  • K864520 — BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON (January 20, 1987)
  • K862524 — DEKNATEL (R) TREPHINE (August 11, 1986)
  • K861825 — CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE (June 9, 1986)
  • K860648 — BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA (March 25, 1986)
  • K843646 — STEINWAY MICRO-KERATO-TREPHINE (January 3, 1985)
  • K843048 — RING SUPPORTED TREPHINE FOR CORNEA TRANS (October 5, 1984)
  • K812723 — PEARCE CORNEAL TREPHINE (October 13, 1981)
  • K781411 — CORNEAL CUTTER AND ACCESSORIES (September 20, 1978)

FDA data resources