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510(k) K841101

CLAYMAN-PAREL CAPSULE COUPEUR by Miami Eye Technology, Inc. — Product Code HNY

K841101 is an FDA 510(k) premarket notification submitted by Miami Eye Technology, Inc. for the device "CLAYMAN-PAREL CAPSULE COUPEUR". The FDA issued a decision of Substantially Equivalent on May 16, 1984. The device falls under product code HNY (Cystotome), a Class I device regulated under 21 CFR 886.4350. Miami Eye Technology, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1984
Date Received
March 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystotome
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Miami Eye Technology, Inc.

  • K832912 — GELENDER VACUUM FIXATION RING SYS (January 10, 1984)
  • K832996 — SURGICAL IOP MONITOR (November 28, 1983)
  • K832997 — EPA AUTOMATED INFUSION POLE (October 4, 1983)
  • K832911 — ABBOTT GLOBE HOLDER (September 29, 1983)
  • K831702 — RARE-EARTH INTRA-OCULAR MAGNET (June 30, 1983)

Other clearances for product code HNY

  • K961524 — STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPU (May 16, 1996)
  • K880345 — CYSTOTOMES/KNIFES (May 3, 1988)
  • K874976 — PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K874975 — PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME (April 13, 1988)
  • K874997 — PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME (April 13, 1988)
  • K874983 — PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME (April 13, 1988)
  • K874993 — PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K875001 — PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME (April 13, 1988)
  • K873163 — VAN DELLEN IRRIGATING CYSTOTOME (September 4, 1987)
  • K871365 — CAPSULECTOMER CYSTOTOME (April 16, 1987)

FDA data resources