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510(k) K980400

PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 by Peregrine Surgical , Ltd. — Product Code HQE

K980400 is an FDA 510(k) premarket notification submitted by Peregrine Surgical , Ltd. for the device "PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10". The FDA issued a decision of Substantially Equivalent on April 30, 1998. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Peregrine Surgical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1998
Date Received
February 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
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 HQE

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • K170183 — Cetus system, Cetus probe (September 27, 2017)
  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121675 — VERSAVIT (June 21, 2012)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)

FDA data resources