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510(k) K874164

GUIDE WIRE by Endovations — Product Code EZB

K874164 is an FDA 510(k) premarket notification submitted by Endovations for the device "GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on December 7, 1987. The device falls under product code EZB (Stylet For Catheter, Gastro-Urology), a Class I device regulated under 21 CFR 876.5130. Endovations has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1987
Date Received
October 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet For Catheter, Gastro-Urology
Device Class
Class I
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Endovations

  • K955413 — ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER (February 8, 1996)
  • K942110 — INJECT-SNARE (October 13, 1994)
  • K944049 — OXYGEN MOUTHGUARD (October 11, 1994)
  • K934315 — ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME (February 28, 1994)
  • K913841 — 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH (October 8, 1991)
  • K913870 — 5MM MICROSCISSORS (September 16, 1991)
  • K911155 — OVAL CUP BIOPSY FORCEP (August 7, 1991)
  • K892218 — ENDO-SPONGE (May 31, 1989)
  • K883093 — TRANSENDOSCOPIC ASPIRATION NEEDLE (December 8, 1988)
  • K873360 — ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG (March 30, 1988)

Other clearances for product code EZB

  • K971498 — APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE (May 5, 1997)
  • K970994 — CORE AND COIL ASSEMBLY GUIDEWIRE (March 25, 1997)

FDA data resources