Home / 510(k) Clearances / K915089

510(k) K915089

MITEK QUICKANCHOR(TM), MODIFICATION by Mitek Surgical Products, Inc. — Product Code GAS

K915089 is an FDA 510(k) premarket notification submitted by Mitek Surgical Products, Inc. for the device "MITEK QUICKANCHOR(TM), MODIFICATION". The FDA issued a decision of Substantially Equivalent on February 3, 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
February 3, 1992
Date Received
November 12, 1991
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)
  • K923161 — BRAIDED POLYESTER SUTURE MATERIAL (December 30, 1992)
  • K913101 — PETERS CARDIOFLON(TM) SUTURE (August 12, 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