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510(k) K861334

CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE by Cilco, Inc. — Product Code HNN

K861334 is an FDA 510(k) premarket notification submitted by Cilco, Inc. for the device "CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code HNN (Knife, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Cilco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
April 9, 1986
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 Cilco, Inc.

  • K854969 — CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) (February 27, 1986)
  • K844249 — K-SOL (April 30, 1985)
  • K843319 — CILCO I/A SURGICAL PACK (February 14, 1985)
  • K843992 — CILCOR OPHTHALMIC INSTRUMENTS (November 21, 1984)
  • K843447 — CILCO DIAMOND KNIFE (October 5, 1984)
  • K841099 — OCTOPUS 500/500E (June 19, 1984)
  • K840475 — CYSTOTOME, 140-S (April 5, 1984)
  • K832405 — OPTHALMIC ENDOSCOPE (November 21, 1983)
  • K827371 — CILCO ASCAN (July 9, 1982)
  • K820933 — CILCO I/A HANDPIECE (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