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510(k) K881858

ACE ICPM SIDE PORTED NEEDLE by Buckman Co., Inc. — Product Code LXC

K881858 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACE ICPM SIDE PORTED NEEDLE". The FDA issued a decision of Substantially Equivalent on May 27, 1988. The device falls under product code LXC (Monitor, Pressure, Intracompartmental), a Class U device. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1988
Date Received
May 3, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Pressure, Intracompartmental
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Buckman Co., Inc.

  • K961320 — CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM (June 25, 1998)
  • K974641 — FUTURELASE 3000/3002 ERBIUM LASER SYSTEM (June 8, 1998)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM (January 16, 1997)
  • K960451 — WEBB-MORLEY SPINE SYSTEM (April 18, 1996)
  • K950999 — KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS (January 25, 1996)
  • K945756 — IMAGN(TM) 2000 SYSTEM (December 19, 1995)
  • K940003 — VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (October 19, 1995)
  • K951117 — LIHTAN 532 LASER (October 18, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)

Other clearances for product code LXC

  • K251900 — MY01 Continuous Compartmental Pressure Monitor (January 16, 2026)
  • K242997 — MY01 Continuous Compartmental Pressure Monitor (March 13, 2025)
  • K223509 — Compremium Compartment Compressibility Monitoring System (CPM#1) (April 14, 2023)
  • K220952 — MY01 Continuous Compartmental Pressure Monitor (May 24, 2022)
  • K210525 — MY01 Continuous Compartmental Pressure Monitor (April 22, 2021)
  • K202635 — MY01 Continuous Compartmental Pressure Monitor (December 10, 2020)
  • K193321 — MY01 Continuous Compartmental Pressure Monitor (July 30, 2020)
  • K131966 — TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER S (February 7, 2014)
  • K090961 — TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS (June 12, 2009)
  • K060963 — TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONI (June 6, 2006)

FDA data resources