Medical Device Manufacturer · US , Reading , PA

Surgical Specialties Corp - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2000
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Surgical Specialties Corp General & Plastic Surgery
19 devices
1-19 of 19
Cleared Jul 18, 2014
POLYSYN SURGICAL SUTURE
K141625 · GAM
General & Plastic Surgery · 31d
Cleared Jul 11, 2014
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
K141558 · GAM
General & Plastic Surgery · 29d
Cleared Feb 28, 2014
MONODERM SURGICAL SUTURE
K140227 · GAM
General & Plastic Surgery · 29d
Cleared Apr 23, 2008
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
K080985 · NEW
General & Plastic Surgery · 16d
Cleared Mar 21, 2008
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
K080680 · NEW
General & Plastic Surgery · 11d
Cleared Aug 06, 2007
QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
K071989 · NEW
General & Plastic Surgery · 17d
Cleared Aug 03, 2007
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
K072028 · GAM
General & Plastic Surgery · 10d
Cleared May 09, 2007
SHARPOINT PDO (POLYDIOXANONE) SUTURES
K063680 · NEW
General & Plastic Surgery · 149d
Cleared Jan 18, 2006
CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
K053380 · NEW
General & Plastic Surgery · 44d
Cleared Dec 06, 2005
OPTIMIZED BARB DESIGN
K052962 · GAW
General & Plastic Surgery · 46d
Cleared Nov 07, 2005
MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
K052437 · GAM
General & Plastic Surgery · 62d
Cleared Apr 01, 2005
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
K050548 · GAW
General & Plastic Surgery · 30d
Cleared Mar 09, 2005
SHARPOINT LUKENS BONE WAX
K050292 · MTJ
General & Plastic Surgery · 30d
Cleared Mar 04, 2005
CONTOUR NECKLIFT THREADS
K050247 · GAW
General & Plastic Surgery · 30d
Cleared Dec 03, 2004
CONTOUR FOREHEAD/BROWLIFT THREAD
K042856 · GAW
General & Plastic Surgery · 60d
Cleared Sep 20, 2004
FEATHERLIFT EXTENDED LENGTH APTOS THREAD
K041593 · GAW
General & Plastic Surgery · 98d
Cleared May 18, 2004
MONODERM
K040477 · GAM
General & Plastic Surgery · 84d
Cleared Jan 28, 2002
SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED
K014021 · GAM
General & Plastic Surgery · 53d
Cleared Dec 15, 2000
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
K003015 · GAN
General & Plastic Surgery · 79d
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