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510(k) K830040

DISPOSABLE CYSTOTOME by Contemporary Surgical Systems, Inc. — Product Code HNY

K830040 is an FDA 510(k) premarket notification submitted by Contemporary Surgical Systems, Inc. for the device "DISPOSABLE CYSTOTOME". The FDA issued a decision of Substantially Equivalent on February 7, 1983. The device falls under product code HNY (Cystotome), a Class I device regulated under 21 CFR 886.4350. Contemporary Surgical Systems, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1983
Date Received
January 7, 1983
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 Contemporary Surgical Systems, Inc.

  • K800110 — X-FLO (February 6, 1980)
  • K791917 — X-PAK (October 30, 1979)

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)
  • K874983 — PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME (April 13, 1988)
  • K874997 — PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME (April 13, 1988)
  • K874976 — PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K873163 — VAN DELLEN IRRIGATING CYSTOTOME (September 4, 1987)
  • K871365 — CAPSULECTOMER CYSTOTOME (April 16, 1987)

FDA data resources