510(k) K033579

REPROCESSED MULTIPLE CLIP APPLIERS by Clearmedical, Inc. — Product Code NMJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 11, 2005
Date Received: November 13, 2003
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Clip, Implantable, Reprocessed
Device Class: Class II
Regulation Number: 878.4300
Review Panel: SU
Submission Type

The "implantable clip, reprocessed" is intended to connect internal tissues to aid in healing. It is not absorbable. 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.

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)
K033593 — REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS (November 20, 2003)
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)