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510(k) K840855

CORNEAL SCLERAL LANCE by Sharpoint, Inc. — Product Code HNN

K840855 is an FDA 510(k) premarket notification submitted by Sharpoint, Inc. for the device "CORNEAL SCLERAL LANCE". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code HNN (Knife, Ophthalmic), 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
May 9, 1984
Date Received
February 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Ophthalmic
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)
  • K840659 — ANTERIOR CAPSULECTOMY CYSTITOME (March 16, 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 HNN

  • K110166 — CLEARCUT S SAFETY KNIFE (May 20, 2011)
  • K922378 — OPHTHALMIC KNIFE (December 10, 1992)
  • K882402 — RETRACTIVE INCISION MICROMETER (RIM) GUAGE (August 22, 1988)
  • K881669 — MVR/STILETTO BLADE 20GA. - P/N 1900 (May 13, 1988)
  • K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE (April 13, 1988)
  • K874057 — OPHTHALMIC TIP & BLADE SCALPELS (December 23, 1987)
  • K874056 — OPHTHALMIC DISPOSABLE BLADES (December 22, 1987)
  • K873385 — OPHTHALMIC PHACO-BLADE (September 21, 1987)
  • K871285 — KNIFE, OPHTHALMIC (April 27, 1987)
  • K864290 — RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE (December 15, 1986)

FDA data resources