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510(k) K923161

BRAIDED POLYESTER SUTURE MATERIAL by Mitek Surgical Products, Inc. — Product Code GAS

K923161 is an FDA 510(k) premarket notification submitted by Mitek Surgical Products, Inc. for the device "BRAIDED POLYESTER SUTURE MATERIAL". The FDA issued a decision of Substantially Equivalent on December 30, 1992. The device falls under product code GAS (Suture, Nonabsorbable, Synthetic, Polyester), a Class II device regulated under 21 CFR 878.5000. Mitek Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1992
Date Received
June 29, 1992
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 Mitek Surgical Products, Inc.

  • K953560 — MITEK THREADED ANCHOR (FASTIN) (January 31, 1996)
  • K953877 — MITEK GII ANCHOR (December 29, 1995)
  • K936311 — MITEK MINI ANCHOR (October 31, 1995)
  • K941599 — MITEK ABSORBABLE ANCHOR (October 24, 1995)
  • K944051 — ABSORBALBE ANCHOR (August 2, 1995)
  • K950070 — MITEK TOGGLE ANCHOR(TM) (May 22, 1995)
  • K944936 — MITEK G III ANCHOR, MITEK LS ANCHOR (March 24, 1995)
  • K945203 — MITEK THRADED ANCHOR (MTA) (March 6, 1995)
  • K934366 — MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER (October 7, 1994)
  • K931782 — MITEK GIII ANCHOR (July 22, 1994)

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)
  • 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)

FDA data resources