510(k) K033593

REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS by Clearmedical, Inc. — Product Code NLU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 20, 2003
Date Received: November 13, 2003
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

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 Clearmedical, Inc.

K033579 — REPROCESSED MULTIPLE CLIP APPLIERS (July 11, 2005)
K033578 — REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS (July 11, 2005)
K033591 — REPROCESSED TROCARS (June 3, 2005)
K033592 — REPROCESSED SURGICAL SCISSORS AND GRASPERS (July 27, 2004)
K031416 — CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSU (July 15, 2003)
K012600 — CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L (July 3, 2002)
K012609 — CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 (July 3, 2002)
K012622 — CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 (July 3, 2002)
K012621 — CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT (February 6, 2002)
K012616 — CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STAND (February 6, 2002)

510(k) K033593

Clearance Details

Device Classification

Other clearances by Clearmedical, Inc.

Other clearances for product code NLU