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510(k) K912089

MODIFIED SERIES 2100 ENDOSCOPES by Medical Laser, Inc. — Product Code ODF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 12, 1991
Date Received: May 13, 1991
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 Medical Laser, Inc.

K913136 — LASER ENDOSCOPE DISC DECOMPRESSION KITS (November 1, 1991)
K912265 — MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 (October 10, 1991)
K912447 — SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 (September 27, 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)

Other clearances for product code ODF

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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)
K910732 — CANDELA MINI-UB ENDOSCOPE (April 12, 1991)