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510(k) K812723

PEARCE CORNEAL TREPHINE by Visitec Co. — Product Code HRH

K812723 is an FDA 510(k) premarket notification submitted by Visitec Co. for the device "PEARCE CORNEAL TREPHINE". The FDA issued a decision of Substantially Equivalent on October 13, 1981. The device falls under product code HRH (Trephine, Manual, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Visitec Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1981
Date Received
September 28, 1981
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 Visitec Co.

  • K953394 — VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} (October 12, 1995)
  • K945114 — VISITEC SCLERAL PLUG (February 23, 1995)
  • K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (February 14, 1995)
  • K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (January 17, 1995)
  • K942234 — VISITEC PRECISE-POINT (July 12, 1994)
  • K934269 — FIBEROPTIC ILLUMINATED INSTRUMENTS (May 17, 1994)
  • K940210 — VISITEC EYE PAD (March 7, 1994)
  • K933872 — VISI-SPEAR EYE SPONGE (December 27, 1993)
  • K923972 — OPHTHALMIC FLUID DISTRIBUTION SETS (November 4, 1992)
  • K922530 — VISITEC MICROSURGICAL SUTURE (October 20, 1992)

Other clearances for product code HRH

  • K022843 — GAYHEART CORNEAL EXCISION DEVICE (November 1, 2002)
  • 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)
  • K781411 — CORNEAL CUTTER AND ACCESSORIES (September 20, 1978)

FDA data resources