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510(k) K203081

RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture by Lsi Solutions — Product Code GAS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 24, 2020
Date Received: October 13, 2020
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Suture, Nonabsorbable, Synthetic, Polyester
Device Class: Class II
Regulation Number: 878.5000
Review Panel: SU
Submission Type

Other clearances by Lsi Solutions

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K202551 — Cor-Knot Micro (June 24, 2021)
K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK (November 24, 2020)
K163639 — LS-5 ePTFE Suture (June 2, 2017)
K111014 — LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES (July 13, 2012)
K100593 — SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND AC (October 13, 2010)
K040232 — LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5 (March 1, 2004)
K031443 — LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS (June 18, 2003)
K024301 — LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT (March 24, 2003)

Other clearances for product code GAS

K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK (November 24, 2020)
K091018 — ARTHREX BIOWIRE (July 30, 2010)
K002261 — MR-III (October 23, 2000)
K953128 — SUTURE CORD (February 9, 1996)
K923161 — BRAIDED POLYESTER SUTURE MATERIAL (December 30, 1992)
K913101 — PETERS CARDIOFLON(TM) SUTURE (August 12, 1992)
K915089 — MITEK QUICKANCHOR(TM), MODIFICATION (February 3, 1992)
K915081 — MITEK SNAP PAK(TM), MODIFICATION (January 31, 1992)
K903175 — ADVANCE SUTURE NONABSORBABLE DACRON SUTURE (July 26, 1991)
K905285 — IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (February 11, 1991)