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510(k) K041108

ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA by Iscience Surgical Corporation — Product Code MPA

K041108 is an FDA 510(k) premarket notification submitted by Iscience Surgical Corporation for the device "ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA". The FDA issued a decision of Substantially Equivalent on June 22, 2004. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Iscience Surgical Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2004
Date Received
April 28, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

Other clearances by Iscience Surgical Corporation

  • K050716 — ISCIENCE SURGICAL VISCOINJECTOR (April 21, 2005)

Other clearances for product code MPA

  • K242184 — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (806 (December 4, 2024)
  • K233653 — Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00) (August 5, 2024)
  • K221872 — ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System (March 30, 2023)
  • K202670 — Nam illumination probe with chopper (August 20, 2021)
  • K151604 — 23ga Chandelier Illuminator, 25ga Chandelier Illuminator (September 11, 2015)
  • K143123 — Synergetics PHOTON EX (February 24, 2015)
  • K080067 — ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER (July 18, 2008)
  • K062895 — XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII (October 13, 2006)
  • K062259 — ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 (August 15, 2006)
  • K032598 — SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (November 24, 2003)

FDA data resources