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510(k) K092739

MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE by C-Link Micro Imaging, Inc. — Product Code ODF

K092739 is an FDA 510(k) premarket notification submitted by C-Link Micro Imaging, Inc. for the device "MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE". The FDA issued a decision of Substantially Equivalent on January 12, 2010. The device falls under product code ODF (Mini Endoscope, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2010
Date Received
September 8, 2009
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 for product code ODF

  • 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)
  • K933106 — ENDOSCOPE (October 19, 1993)
  • K912089 — MODIFIED SERIES 2100 ENDOSCOPES (August 12, 1991)
  • K910732 — CANDELA MINI-UB ENDOSCOPE (April 12, 1991)

FDA data resources