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510(k) K980027

PEREGRINE SHIELDED DIFFUSION PROBE by Peregrine Surgical , Ltd. — Product Code MPA

K980027 is an FDA 510(k) premarket notification submitted by Peregrine Surgical , Ltd. for the device "PEREGRINE SHIELDED DIFFUSION PROBE". The FDA issued a decision of Substantially Equivalent on March 31, 1998. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Peregrine Surgical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1998
Date Received
January 5, 1998
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 , Ltd.

  • K233653 — Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00) (August 5, 2024)
  • 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)

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)
  • K041108 — ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA (June 22, 2004)

FDA data resources