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510(k) K873163

VAN DELLEN IRRIGATING CYSTOTOME by Van Dellen, Ltd. — Product Code HNY

K873163 is an FDA 510(k) premarket notification submitted by Van Dellen, Ltd. for the device "VAN DELLEN IRRIGATING CYSTOTOME". The FDA issued a decision of Substantially Equivalent on September 4, 1987. The device falls under product code HNY (Cystotome), a Class I device regulated under 21 CFR 886.4350. Van Dellen, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1987
Date Received
August 11, 1987
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 Van Dellen, Ltd.

  • K873465 — VAN DELLEN BACTERIA FILTER (January 20, 1988)
  • K873464 — VAN DELLEN CANNULA (November 23, 1987)
  • K873463 — VAN DELLEN ASPIRATING TUBING (November 23, 1987)
  • K873462 — VAN DELLEN ASPIRATOR (September 25, 1987)
  • K873162 — VAN DELLEN RETROBULBAR NEEDLE (September 4, 1987)
  • K873164 — VAN DELLEN HEALON CANNULA (September 4, 1987)

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)
  • K875001 — PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME (April 13, 1988)
  • K874975 — PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME (April 13, 1988)
  • K874993 — PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K874976 — PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K874997 — PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME (April 13, 1988)
  • K874983 — PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME (April 13, 1988)
  • K871365 — CAPSULECTOMER CYSTOTOME (April 16, 1987)
  • K870439 — LOOK IRRIGATING CYSTOTOMES (February 20, 1987)

FDA data resources