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510(k) K912265

MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 by Medical Laser, Inc. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1991
Date Received
May 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

Other clearances by Medical Laser, Inc.

  • K913136 — LASER ENDOSCOPE DISC DECOMPRESSION KITS (November 1, 1991)
  • K912447 — SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 (September 27, 1991)
  • K912089 — MODIFIED SERIES 2100 ENDOSCOPES (August 12, 1991)
  • K901464 — MEDILASE SERIES 2200 ENDOSCOPE (August 7, 1990)
  • K900894 — MEDILASE SERIES 2100 ENDOSCOPE (June 22, 1990)
  • K900380 — MEDILASE 5010 ENDOSCOPE CONSOLE (May 15, 1990)
  • K895837 — MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR (December 14, 1989)

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