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510(k) K090159

INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES by Incisive Surgical, Inc. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2009
Date Received
January 22, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

Other clearances by Incisive Surgical, Inc.

  • K120373 — INSORB ABSORBALBE STAPLE (March 16, 2012)
  • K061784 — INSORB ABSORBABLE STAPLE, MODEL 1020 (July 26, 2006)
  • K033602 — INSORB ABSORBABLE STAPLE, MODEL SP-B20 (December 16, 2003)
  • K024117 — INSORB ABSORBABLE STAPLES, MODEL SP-B20 (April 22, 2003)

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