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510(k) K012317

COALESCENT SURGICAL U-CLIP by Coalescent Surgical — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2001
Date Received
July 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Coalescent Surgical

  • K040821 — COALESCENT SURGICAL U-CLIP AND ACCESSORIES (April 23, 2004)
  • K031623 — MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES (July 3, 2003)
  • K024366 — COALESCENT SURGICAL U-CLIP AND ACCESSORIES (January 17, 2003)
  • K023125 — COALESCENT U-CLIP- AND ACCESSORIES (December 18, 2002)
  • K021407 — COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES (July 3, 2002)
  • K013664 — COALESCENT SURGICAL U-CLIP (January 24, 2002)
  • K003958 — COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE (February 6, 2001)
  • K994160 — COALESCENT SURGICAL SUTURED-CLIP (February 4, 2000)

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