SURGICAL SPECIALTIES

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
31
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1534-2024Class IIPOLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503NMarch 26, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K141625POLYSYN SURGICAL SUTUREJuly 18, 2014
K141558QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICEJuly 11, 2014
K140227MONODERM SURGICAL SUTUREFebruary 28, 2014
K080985QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)April 23, 2008
K080680QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONEMarch 21, 2008
K071989QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIALAugust 6, 2007
K072028QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERMAugust 3, 2007
K063680SHARPOINT PDO (POLYDIOXANONE) SUTURESMay 9, 2007
K053380CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTUREJanuary 18, 2006
K052962OPTIMIZED BARB DESIGNDecember 6, 2005
K052437MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURENovember 7, 2005
K050548CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADSApril 1, 2005
K050292SHARPOINT LUKENS BONE WAXMarch 9, 2005
K050247CONTOUR NECKLIFT THREADSMarch 4, 2005
K042856CONTOUR FOREHEAD/BROWLIFT THREADDecember 3, 2004
K041593FEATHERLIFT EXTENDED LENGTH APTOS THREADSeptember 20, 2004
K040477MONODERMMay 18, 2004
K020882SHARPOINT ULTRAPLUG EXTENDED WEAR PLUGJuly 26, 2002
K014021SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYEDJanuary 28, 2002
K003015SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBDDecember 15, 2000