Home / 510(k) Clearances / K904263

510(k) K904263

DACRON R SURGICAL SUTURES by Sharppoint, Inc. — Product Code GAS

K904263 is an FDA 510(k) premarket notification submitted by Sharppoint, Inc. for the device "DACRON R SURGICAL SUTURES". The FDA issued a decision of Substantially Equivalent on October 16, 1990. The device falls under product code GAS (Suture, Nonabsorbable, Synthetic, Polyester), a Class II device regulated under 21 CFR 878.5000.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1990
Date Received
September 17, 1990
Clearance Type
Traditional
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 for product code GAS

  • K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK (November 24, 2020)
  • K203081 — RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (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)

FDA data resources