Home / 510(k) Clearances / K892218

510(k) K892218

ENDO-SPONGE by Endovations — Product Code MNL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1989
Date Received
April 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Cleaning Brushes, For Endoscope
Device Class
Class I
Regulation Number
876.1500
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)
  • K883093 — TRANSENDOSCOPIC ASPIRATION NEEDLE (December 8, 1988)
  • K873360 — ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG (March 30, 1988)
  • K875264 — WASHING CATHETER (March 29, 1988)

Other clearances for product code MNL

  • K950689 — UCB (March 6, 1995)
  • K946293 — MILL-ROSE SCOPE CLEANING BRUSH (February 16, 1995)
  • K874239 — CLEANING BRUSH (December 29, 1987)