510(k) K023767

UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES by The Olympus Optical Co. — Product Code GEI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 29, 2002
Date Received: November 12, 2002
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Electrosurgical, Cutting & Coagulation & Accessories
Device Class: Class II
Regulation Number: 878.4400
Review Panel: SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by The Olympus Optical Co.

K032066 — SONOSURG SYSTEM (October 3, 2003)
K030194 — XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT (March 24, 2003)
K021962 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (February 12, 2003)
K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SE (January 31, 2003)
K023272 — DISPOSABLE ASPIRATION NEEDLE NA-200H (December 23, 2002)
K012074 — XBO1-824-18/19/20 BIOPSY FORCEPS (September 25, 2001)
K012073 — OLYMPUS SPRAY CATHETER PW-6C-1 (August 10, 2001)
K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (July 25, 2001)
K011149 — DISPOSABLE BENDING CANNULA PR-233Q (May 15, 2001)
K011151 — EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (May 15, 2001)

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