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510(k) K141558

QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE by Surgical Specialties Corp — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2014
Date Received
June 12, 2014
Clearance Type
Special
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

Other clearances by Surgical Specialties Corp

  • K141625 — POLYSYN SURGICAL SUTURE (July 18, 2014)
  • K140227 — MONODERM SURGICAL SUTURE (February 28, 2014)
  • 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)
  • K052437 — MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE (November 7, 2005)

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