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510(k) K120373

INSORB ABSORBALBE STAPLE by Incisive Surgical, Inc. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2012
Date Received
February 6, 2012
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.

  • K090159 — INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES (February 6, 2009)
  • 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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