Home / 510(k) Clearances / K913987

510(k) K913987

OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID by Codman & Shurtleff, Inc. — Product Code ITY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1992
Date Received
September 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assembly, Tube Housing, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1760
Review Panel
RA
Submission Type

Other clearances by Codman & Shurtleff, Inc.

  • K193380 — CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (July 20, 2020)
  • K191237 — CERENOVUS Large Bore Catheter (November 8, 2019)
  • K173192 — CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLin (November 8, 2017)
  • K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage Sy (October 16, 2017)
  • K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (October 3, 2017)
  • K171862 — GALAXY G3 Mini Microcoil Delivery System (September 25, 2017)
  • K171747 — MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stre (July 14, 2017)
  • K171653 — YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up (July 3, 2017)
  • K162563 — YOGA Microcatheter (January 5, 2017)
  • K162437 — Codman EDS3 CSF External Drainage System (October 28, 2016)

Other clearances for product code ITY

  • K000052 — X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (February 10, 2000)
  • K933162 — MRX-750 (October 7, 1993)
  • K923094 — MOLYBDENUM (March 4, 1993)
  • K923141 — PHILIPS PRE-FILTER OPTION (January 21, 1993)
  • K921129 — MRX-700 (October 5, 1992)
  • K921130 — MRX-865 (September 10, 1992)
  • K921316 — MG-1001 TUBE HOUSING ASSEMBLY (June 22, 1992)
  • K920731 — X-RAY TUBE ASSEMBLY CIRCLEX1.2UG (May 29, 1992)
  • K920724 — HIGH SPEED ROTATION STARTER SA-50 (April 27, 1992)
  • K920723 — HIGH SPEED ROTATION STARTER SA-40 (April 27, 1992)