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510(k) K950529

PEREGRINE DIFFUSION LIGHT PIPE by Peregrine Surgical , Ltd. — Product Code HJM

K950529 is an FDA 510(k) premarket notification submitted by Peregrine Surgical , Ltd. for the device "PEREGRINE DIFFUSION LIGHT PIPE". The FDA issued a decision of Substantially Equivalent on June 7, 1995. The device falls under product code HJM (Transilluminator, Ac-Powered), a Class II device regulated under 21 CFR 886.1945. Peregrine Surgical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1995
Date Received
February 7, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transilluminator, Ac-Powered
Device Class
Class II
Regulation Number
886.1945
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 HJM

  • K972506 — INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR (October 1, 1997)
  • K945877 — WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (March 2, 1995)
  • K931072 — HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE (November 10, 1994)
  • K933445 — DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) (September 23, 1994)
  • K940393 — PEREGRINE WIDE ANGLE LIGHT PIPE (September 2, 1994)
  • K934269 — FIBEROPTIC ILLUMINATED INSTRUMENTS (May 17, 1994)
  • K913273 — DROLITE(TM) LIGHT SOURCE (December 4, 1991)
  • K894513 — DIATHRON(R) DIATHERMY UNIT (October 31, 1989)
  • K893170 — VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) (June 5, 1989)
  • K812949 — RMI TRANSILLUMINATOR, MODEL 292 (December 2, 1981)

FDA data resources