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510(k) K944051

ABSORBALBE ANCHOR by Mitek Surgical Products, Inc. — Product Code MNV

K944051 is an FDA 510(k) premarket notification submitted by Mitek Surgical Products, Inc. for the device "ABSORBALBE ANCHOR". The FDA issued a decision of Substantially Equivalent on August 2, 1995. The device falls under product code MNV (Strip, Dialysate Ph Indicator), a Class II device regulated under 21 CFR 876.5820. Mitek Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1995
Date Received
August 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Dialysate Ph Indicator
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
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)
  • 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)
  • K931253 — QUICKANCHOR II (June 16, 1994)

Other clearances for product code MNV

  • K101750 — RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST S (January 7, 2011)
  • K031267 — STERICHEK BICARB PH REAGENT STRIPS (December 23, 2003)
  • K936311 — MITEK MINI ANCHOR (October 31, 1995)
  • K941599 — MITEK ABSORBABLE ANCHOR (October 24, 1995)
  • K945491 — SERIM(TM) BICARB PH REAGENT STRIPS (February 1, 1995)

FDA data resources