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510(k) K840659

ANTERIOR CAPSULECTOMY CYSTITOME by Sharpoint, Inc. — Product Code HNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1984
Date Received
February 15, 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 Sharpoint, Inc.

  • K863595 — COATED SUTURE NEEDLE (October 24, 1986)
  • K861947 — SURGICAL KNIFE (June 6, 1986)
  • K840764 — EAR KNIVES (May 21, 1984)
  • K840855 — CORNEAL SCLERAL LANCE (May 9, 1984)
  • K840660 — POSTERIOR CAPSULOTOMY CYSTITOME (March 16, 1984)
  • K830522 — STAINLESS STEEL SUTURE 316L (March 31, 1983)
  • K822112 — OPHTHALMIC KNIFE (August 10, 1982)
  • K821440 — V LANCE (June 14, 1982)

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)
  • 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)
  • K874975 — PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME (April 13, 1988)
  • K873163 — VAN DELLEN IRRIGATING CYSTOTOME (September 4, 1987)
  • K871365 — CAPSULECTOMER CYSTOTOME (April 16, 1987)