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510(k) K945171

DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE by Boston Surgical Products, Inc. — Product Code KYG

K945171 is an FDA 510(k) premarket notification submitted by Boston Surgical Products, Inc. for the device "DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE". The FDA issued a decision of Substantially Equivalent on February 8, 1995. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. Boston Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1995
Date Received
October 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Irrigation, Ocular Surgery
Device Class
Class I
Regulation Number
886.4360
Review Panel
OP
Submission Type

Other clearances by Boston Surgical Products, Inc.

  • K972311 — MODEL 20 BIPOLAR COAGULATOR (September 18, 1997)
  • K972350 — MODEL 50 BIPOLAR COAGULATOR (August 21, 1997)
  • K944947 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS (July 28, 1995)
  • K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS (July 12, 1995)
  • K950375 — DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR (June 14, 1995)
  • K951912 — DISOPOSABLE & RESUABLE MONPOLAR CORD (May 12, 1995)
  • K951269 — DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL (April 24, 1995)
  • K950877 — REUSABLE MONOPOLAR FORCEPS (March 9, 1995)
  • K945893 — DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE (December 13, 1994)
  • K945717 — ELECTROSURGICAL ENDOSCOPIC CORD (December 8, 1994)

Other clearances for product code KYG

  • K010353 — MED-LOGICS DISPOSABLE ALK TUBING (April 27, 2001)
  • K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10102 (December 22, 2000)
  • K993591 — BLADEWORKS DISPOSABLE ALK TUBING (December 28, 1999)
  • K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM (May 19, 1998)
  • K980647 — EYE IRRIGATOR MODEL #2020 (May 15, 1998)
  • K974561 — MOISTAIR FLUID AIR TUBING SET (February 19, 1998)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)
  • K970161 — HEDGES CORNEAL WETTING PAK (March 25, 1997)
  • K954842 — D.O.R.C. VFI/VFE SYSTEM (April 15, 1996)
  • K940392 — PEREGRINE PIC MINIPULATOR (August 23, 1994)

FDA data resources