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510(k) K052437

MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE by Surgical Specialties Corp — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2005
Date Received
September 6, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

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  • K080985 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) (April 23, 2008)
  • K080680 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE (March 21, 2008)
  • K071989 — QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL (August 6, 2007)
  • K072028 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM (August 3, 2007)
  • K063680 — SHARPOINT PDO (POLYDIOXANONE) SUTURES (May 9, 2007)
  • K053380 — CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE (January 18, 2006)
  • K052962 — OPTIMIZED BARB DESIGN (December 6, 2005)

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