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510(k) K840660

POSTERIOR CAPSULOTOMY CYSTITOME by Sharpoint, Inc. — Product Code HNY

K840660 is an FDA 510(k) premarket notification submitted by Sharpoint, Inc. for the device "POSTERIOR CAPSULOTOMY CYSTITOME". The FDA issued a decision of Substantially Equivalent on March 16, 1984. The device falls under product code HNY (Cystotome), a Class I device regulated under 21 CFR 886.4350. Sharpoint, Inc. has at least 8 other 510(k) clearances on record.

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)
  • K840659 — ANTERIOR CAPSULECTOMY 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)
  • 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