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510(k) K903175

ADVANCE SUTURE NONABSORBABLE DACRON SUTURE by Advance Suture, Inc. — Product Code GAS

K903175 is an FDA 510(k) premarket notification submitted by Advance Suture, Inc. for the device "ADVANCE SUTURE NONABSORBABLE DACRON SUTURE". The FDA issued a decision of Substantially Equivalent on July 26, 1991. The device falls under product code GAS (Suture, Nonabsorbable, Synthetic, Polyester), a Class II device regulated under 21 CFR 878.5000. Advance Suture, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1991
Date Received
July 18, 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 by Advance Suture, Inc.

  • K903174 — ADVANCE SUTURE ABSORBABLE GUT SUTURE (July 10, 1991)
  • K903176 — ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE (June 28, 1991)
  • K903177 — ADVANCE SUTURE NONABSORBABLE NYLON SUTURE (June 28, 1991)
  • K905454 — ADVANCE SUTURE NONABSORBABLE SILK SUTURE (June 28, 1991)

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)
  • K905285 — IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (February 11, 1991)

FDA data resources