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510(k) K883858

FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE by Advanced Surgical Products, Inc. — Product Code HBI

K883858 is an FDA 510(k) premarket notification submitted by Advanced Surgical Products, Inc. for the device "FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE". The FDA issued a decision of Substantially Equivalent on September 29, 1988. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Advanced Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1988
Date Received
September 13, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Fiberoptic, Surgical Field
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
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 HBI

  • K223183 — Light-Guide Cables (January 13, 2023)
  • K163185 — OptiLux LED Illuminator (November 21, 2016)
  • K141781 — KOGENT SPETZLER LIGHTED SUCTION TUBES (April 9, 2015)
  • K111342 — LIGHT GUIDE CABLE (November 25, 2011)
  • K052979 — 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE (October 31, 2005)
  • K021931 — ENDOSCOPIC FIBEROPTIC CABLE (September 6, 2002)
  • K991208 — ENDOSCOPIC FIBEROPTIC CABLE (June 23, 1999)
  • K983277 — LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (December 16, 1998)
  • K933593 — LUMINOUS 150 FIBEROPTIC ILLUMINATOR (October 28, 1993)
  • K922837 — S1500 XENON LIGHT SOURCE (November 3, 1992)

FDA data resources