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510(k) K860246

ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE by Buckman Co., Inc. — Product Code PUP

K860246 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on April 2, 1986. The device falls under product code PUP (Endoscope Maintenance System), a Class II device regulated under 21 CFR 876.1500. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1986
Date Received
January 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Maintenance System
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
Submission Type

To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments.

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)

FDA data resources