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510(k) K821381

IOL FORCEPS by Cilco, Inc. — Product Code KYB

K821381 is an FDA 510(k) premarket notification submitted by Cilco, Inc. for the device "IOL FORCEPS". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. Cilco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
May 10, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

Other clearances by Cilco, Inc.

  • K861334 — CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE (May 2, 1986)
  • 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)

Other clearances for product code KYB

  • K152357 — MicroSTAAR Injector System Cartridges (October 30, 2015)
  • K081382 — DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 (October 23, 2008)
  • K072985 — DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (June 20, 2008)
  • K070669 — IOL INJECTOR SET (November 1, 2007)
  • K063155 — MONARCH III IOL DELIVERY SYSTEM (March 27, 2007)
  • K063694 — AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (March 7, 2007)
  • K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S (June 10, 2004)
  • K022723 — MASTEL 1 FOLDER IMPLANTATION SYSTEM (December 26, 2002)
  • K001157 — MONARCH II IOL DELIVERY SYSTEM (June 27, 2000)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)

FDA data resources