Home / 510(k) Clearances / K874984

510(k) K874984

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

K874984 is an FDA 510(k) premarket notification submitted by Advanced Surgical Products, Inc. for the device "PRISMA DISPOSABLE MICRO IRRIGATING VECTUS". The FDA issued a decision of Substantially Equivalent on April 13, 1988. The device falls under product code HMX (Cannula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Advanced Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K030926 — FAST THROW STAINLESS STEEL SURGICAL SUTURE (July 21, 2003)
  • K895800 — ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR (January 22, 1990)
  • 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)
  • K883856 — FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE (September 29, 1988)
  • K883857 — FIBEROPTIC WIRE 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)

FDA data resources