Home / 510(k) Clearances / K862107

510(k) K862107

PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR by Penn Medical Devices, Inc. — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1986
Date Received
June 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

Other clearances by Penn Medical Devices, Inc.

  • K873949 — RORERTAZZI NASOPHARYNGEAL AIRWAY (October 20, 1987)
  • K873177 — DEVINE (SUPRAPUBIC SOUND AND GUIDE) (October 14, 1987)
  • K873176 — HUFFMAN BIOPSY UNIT (October 14, 1987)
  • K873178 — URETERAL BULB DILATORS (September 30, 1987)
  • K871667 — URETERAL STENT (June 10, 1987)
  • K870508 — GASTROINTESTINAL TUBE (May 11, 1987)
  • K862729 — PENN 3-RING HANDLE (October 24, 1986)

Other clearances for product code ODC

  • K250145 — Biopsy Port Adapter (October 17, 2025)
  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (July 16, 2025)
  • K250732 — Disposable Endoscopy Valve Set (June 20, 2025)
  • K241842 — Luer-Split MAJ-2092 (March 19, 2025)
  • K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter (February 20, 2025)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)
  • K241285 — Disposable Endoscope Valves Set (AF series) (October 1, 2024)
  • K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Si (March 22, 2024)