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510(k) K031869

SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES by Surgical Instruments Service and Savings, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2003
Date Received
June 17, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Surgical Instruments Service and Savings, Inc.

  • K124033 — MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS (January 7, 2014)
  • K030179 — MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES (January 24, 2003)
  • K024011 — SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICA (December 19, 2002)
  • K012644 — REPROCESSED TROCARS AND CANNULAS (July 29, 2002)
  • K012669 — REPROCESSED ELECTROSURGICAL ELECTRODES (June 27, 2002)
  • K012667 — REPROCESSED ARTHROSCOPIC SHAPERS (June 3, 2002)
  • K012658 — REPROCESSED COMPRESSION LIMB SLEEVES (May 14, 2002)

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