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510(k) K961524

STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS by Sterilab, Inc. — Product Code HNY

K961524 is an FDA 510(k) premarket notification submitted by Sterilab, Inc. for the device "STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS". The FDA issued a decision of Substantially Equivalent on May 16, 1996. The device falls under product code HNY (Cystotome), a Class I device regulated under 21 CFR 886.4350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1996
Date Received
April 22, 1996
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 for product code HNY

  • K880345 — CYSTOTOMES/KNIFES (May 3, 1988)
  • K874976 — PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K875001 — PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME (April 13, 1988)
  • K874997 — PRISMA DISPOSABLE STRAIGHT 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)
  • K873163 — VAN DELLEN IRRIGATING CYSTOTOME (September 4, 1987)
  • K871365 — CAPSULECTOMER CYSTOTOME (April 16, 1987)
  • K870439 — LOOK IRRIGATING CYSTOTOMES (February 20, 1987)

FDA data resources