Name: Predicase
Price: 199 USD

K-number	K232246
Device name	1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture
Applicant	M/s. Meril Endo Surgery Private Limited.
Product code	NEW
Device class	Class II
Decision date	Apr 25, 2024
Decision	Substantially Equivalent
Regulation	878.4840

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Source

View the full FDA submission: accessdata.fda.gov

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1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture

Everything you need for a 510(k) submission. Nothing you don't.

1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture