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510(k) K933106

ENDOSCOPE by Origin Medsystems, Inc. — Product Code ODF

K933106 is an FDA 510(k) premarket notification submitted by Origin Medsystems, Inc. for the device "ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on October 19, 1993. The device falls under product code ODF (Mini Endoscope, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Origin Medsystems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1993
Date Received
June 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mini Endoscope, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Origin Medsystems, Inc.

  • K992353 — BLUNT TIP TROCAR PORT (July 30, 1999)
  • K981700 — VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM (May 29, 1998)
  • K972685 — ORIGIN LIGATOR DEVICE (October 1, 1997)
  • K970611 — ORIGIN CARDIAC STABLIZER OCCLUDER (August 19, 1997)
  • K965121 — CANNULA (March 20, 1997)
  • K964171 — VASOVIEW BALLOON DISSECTION SYSTEM (February 14, 1997)
  • K962104 — AIRLIFT BALLOON RETRACTON SYSTEM (September 11, 1996)
  • K962005 — EXTRAHAND BALLOON RETRACTOR (August 12, 1996)
  • K960936 — RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] (July 24, 1996)
  • K960637 — 5MM ENDOSCOPE (June 14, 1996)

Other clearances for product code ODF

  • K092739 — MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DU (January 12, 2010)
  • K091962 — POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOU (September 30, 2009)
  • K090170 — SPYSCOPE ACCESS AND DELIVERY CATHETER (February 4, 2009)
  • K052194 — SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR (August 24, 2005)
  • K050403 — SPYGLASS DIRECT VISULATION PROBE (March 4, 2005)
  • K963354 — 5 STAR MEDICAL ENDOSCOPE (September 8, 1997)
  • K943593 — SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM (March 22, 1995)
  • K941230 — MINI-UB ENDOSCOPES (June 17, 1994)
  • K912089 — MODIFIED SERIES 2100 ENDOSCOPES (August 12, 1991)
  • K910732 — CANDELA MINI-UB ENDOSCOPE (April 12, 1991)

FDA data resources