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510(k) K945738

VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE by Visitec Co. — Product Code HMT

K945738 is an FDA 510(k) premarket notification submitted by Visitec Co. for the device "VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE". The FDA issued a decision of Substantially Equivalent on February 14, 1995. The device falls under product code HMT (Drape, Patient, Ophthalmic), a Class II device regulated under 21 CFR 878.4370. Visitec Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1995
Date Received
November 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Patient, Ophthalmic
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Visitec Co.

  • K953394 — VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} (October 12, 1995)
  • K945114 — VISITEC SCLERAL PLUG (February 23, 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)
  • K923645 — VISITEC ASPIRATING SYRINGE (September 30, 1992)

Other clearances for product code HMT

  • K905460 — STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY (February 6, 1991)
  • K872620 — SOLOS EYESITE DRAPES (July 31, 1987)
  • K871706 — OPTHA PREP (May 18, 1987)
  • K854613 — SURGICAL DRAPES, OPHTHALMIN (February 13, 1986)
  • K831340 — DRAIN-R-DRAPE(EYE (June 8, 1983)
  • K830822 — EYE DRAPE (April 6, 1983)

FDA data resources