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510(k) K233653

Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) by Peregrine Surgical, LLC — Product Code MPA

K233653 is an FDA 510(k) premarket notification submitted by Peregrine Surgical, LLC for the device "Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)". The FDA issued a decision of Substantially Equivalent on August 5, 2024. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Peregrine Surgical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2024
Date Received
November 14, 2023
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 Peregrine Surgical, LLC

  • K151604 — 23ga Chandelier Illuminator, 25ga Chandelier Illuminator (September 11, 2015)
  • K132614 — PEREGRINE CURVED ILLUMINATING LASER PROBE (November 14, 2013)
  • K122997 — 23GA CURVED ILLUMINATING LASER PROBE (June 26, 2013)
  • K122905 — PEREGRINE 23GA CURVED LASER PROBE (April 30, 2013)
  • K061024 — PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 (June 21, 2006)
  • K031023 — PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 (June 27, 2003)
  • K024061 — PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 (March 7, 2003)
  • K990518 — PEREGRINE WET SET, MODEL PD400.00 (March 25, 1999)
  • K981907 — V.F.I.-VISCOUS FLUID INFUSION TUBING SET (August 4, 1998)
  • K980797 — PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR (May 19, 1998)

Other clearances for product code MPA

  • K242184 — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (806 (December 4, 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)
  • K041108 — ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA (June 22, 2004)
  • K032598 — SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (November 24, 2003)

FDA data resources