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510(k) K874971

PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS by Advanced Surgical Products, Inc. — Product Code HMX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1988
Date Received
December 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Advanced Surgical Products, Inc.

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  • K896754 — I/A HANDPIECE (January 11, 1990)
  • K896305 — MULTI-USE I/A HANDPIECE (December 18, 1989)
  • K884557 — ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE (May 12, 1989)
  • K884556 — DREYER CURVED ENDOILLUMINATOR (February 28, 1989)
  • K890398 — RYAN-STYLE DIRECTED INFUSION MANIPULATOR (February 17, 1989)
  • K884347 — MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN (December 27, 1988)
  • K883857 — FIBEROPTIC WIRE PICK LIGHTPIPE (September 29, 1988)
  • K883858 — FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE (September 29, 1988)

Other clearances for product code HMX

  • K010305 — WEISS RETINAL CANNULA (May 2, 2001)
  • K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAM (May 9, 2000)
  • K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (May 20, 1997)
  • K943932 — STERISEAL OPHTHALMIC CANNULA (January 18, 1995)
  • K942403 — INFUSION CANNULA (August 17, 1994)
  • K934844 — INTER TIP T (April 19, 1994)
  • K930113 — KIRWAN IRRIGATION/ASPIRATION HANDPIECE (February 17, 1994)
  • K921488 — ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION (May 7, 1992)
  • K915074 — IRRIGATOR/ASPIRATOR PROBE (February 5, 1992)
  • K904074 — VITREORETINAL INFUSION CANNULA (February 26, 1991)