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510(k) K233265

Monotime and Optime R by Peters Surgical — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2024
Date Received
September 29, 2023
Clearance Type
Abbreviated
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 Peters Surgical

  • K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (July 12, 2024)
  • K071281 — UNIRING - ANNULOPLASTY RING WITH SIZERS (August 3, 2007)
  • K060465 — PREMIO (January 17, 2007)
  • K060163 — CARDIOFLON, CARDIOXYL (October 11, 2006)
  • K062366 — OPTIME, SINUSORB PGA (October 2, 2006)
  • K052701 — COROLENE (December 13, 2005)

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  • K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (July 12, 2024)
  • K221527 — StitchKit (February 14, 2023)
  • K221744 — STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (November 15, 2022)
  • K212810 — MONOFIX PGCL, knotless wound closure device (August 5, 2022)
  • K211792 — StitchKit (July 16, 2021)
  • K202950 — StitchKit COMBO (February 23, 2021)