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510(k) K023125

COALESCENT U-CLIP- AND ACCESSORIES by Coalescent Surgical — Product Code NJU

K023125 is an FDA 510(k) premarket notification submitted by Coalescent Surgical for the device "COALESCENT U-CLIP- AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on December 18, 2002. The device falls under product code NJU (Suture, Nonabsorbable, Nitinol), a Class II device regulated under 21 CFR 878.4495. Coalescent Surgical has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2002
Date Received
September 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Nitinol
Device Class
Class II
Regulation Number
878.4495
Review Panel
SU
Submission Type

Soft tissue approximation.

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)
  • K021407 — COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES (July 3, 2002)
  • K013664 — COALESCENT SURGICAL U-CLIP (January 24, 2002)
  • K012317 — COALESCENT SURGICAL U-CLIP (August 31, 2001)
  • K003958 — COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE (February 6, 2001)
  • K994160 — COALESCENT SURGICAL SUTURED-CLIP (February 4, 2000)

Other clearances for product code NJU

  • K023372 — NON-BIOABSORBABLE STAPLE (December 27, 2002)

FDA data resources