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510(k) K024011

SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES by Surgical Instruments Service and Savings, Inc. — Product Code NLU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2002
Date Received
December 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Forceps, Biopsy, Electric, Reprocessed
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

The "forceps, biopsy, electric, reprocessed" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3) destroy the residuum of the lesion being biopsied. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Surgical Instruments Service and Savings, Inc.

  • K124033 — MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS (January 7, 2014)
  • K031869 — SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSOR (December 24, 2003)
  • K030179 — MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES (January 24, 2003)
  • 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)

Other clearances for product code NLU

  • K050136 — REPROCESSED HOT BIOPSY FORCEPS (July 20, 2005)
  • K033593 — REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS (November 20, 2003)
  • K011800 — VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS (September 27, 2001)