Home / 510(k) Clearances / K952535

510(k) K952535

ACUFEX ENDOBUTTON TAPE by Acufex Microsurgical, Inc. — Product Code GAT

Clearance Details

Decision
SN ()
Decision Date
February 8, 1996
Date Received
June 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Acufex Microsurgical, Inc.

  • K961555 — ACUFEX TAG BIOABSORBABLE ANCHORS (July 10, 1996)
  • K961853 — PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER (June 21, 1996)
  • K954246 — ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW (February 15, 1996)
  • K953276 — ACUFEX TAG DELIVERY SYSTEM (October 5, 1995)
  • K953459 — ACUFEX TAG ANCHOR (August 23, 1995)
  • K941740 — ACUFEX ROTATOR CUFF FIXATION BUTTON (June 30, 1995)
  • K944500 — ACUFEX PATELLAR BONE BLOCK SIZER (June 12, 1995)
  • K951859 — ACUFEX ENDOBUTTON PACK (June 9, 1995)
  • K946346 — ACUFEX TAG(R) BIOABSORBABLE ANCHORS (April 26, 1995)
  • K941709 — ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS (April 14, 1995)

Other clearances for product code GAT

  • K254188 — Meniscus Versaflex (February 19, 2026)
  • K253145 — Pre-Sutured Tendon (October 22, 2025)
  • K253024 — ProZip Knotless Implant (October 16, 2025)
  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K242201 — HyperSuture White/Green Extension Line (March 27, 2025)
  • K241376 — HyperSuture All Blue Extension Line (August 9, 2024)
  • K234079 — HyperSuture Extension Line (May 10, 2024)
  • K231163 — HS Fiber Sutures (January 5, 2024)
  • K230311 — HyperSuture (November 24, 2023)