Panels › General, Plastic Surgery › Product code NEW · Class 2
Suture, Surgical, Absorbable, Polydioxanone
Regulation 878.4840
6510(k)s in 12 months (67 all time)
0recalls in 12 months (40 all time)
32recalls that name a 510(k)
Top companies in NEW
| Company | 510(k)s | Recalls |
|---|---|---|
| ETHICON, Inc. | 9 | 24 |
| DePuy Mitek, Inc., a Johnson & Johnson Co. | 0 | 5 |
| Surgical Specialties Corp | 5 | 0 |
| C P Medical | 0 | 4 |
| Ethicon Endo Surgery, LLC | 0 | 4 |
| Hans Biomed Corporation | 4 | 0 |
| Demetech Corp. | 3 | 0 |
| Depuy Mitek | 3 | 0 |
| Feeltech Co., Ltd. | 3 | 0 |
| Surgical Specialties Corp. Dba Angiotech | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 2008 | K080680 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE Surgical Specialties Corp | NEW |
| Aug 6, 2007 | K071989 | QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL Surgical Specialties Corp | NEW |
| May 9, 2007 | K063680 | SHARPOINT PDO (POLYDIOXANONE) SUTURES Surgical Specialties Corp | NEW |
| Jul 14, 2006 | K061037 | PDS PLUS ANTIBACTERIAL SUTURE ETHICON, Inc. | NEW |
| Jan 18, 2006 | K053380 | CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE Surgical Specialties Corp | NEW |
| Aug 4, 2005 | K051609 | QUILL SYNTHETIC ABSORBABLE BARBED SUTURE Quill Medical, Inc. | NEW |
| Dec 10, 2004 | K043298 | BLUE ORTHOCORD SUTURE Depuy Mitek | NEW |
| Dec 10, 2004 | K042285 | UNICRYL M United Medical Industries Co. , Ltd., SA | NEW |
| Oct 26, 2004 | K042075 | QUILL SYNTHETIC ABSORBABLE BARBED SUTURE Quill Medical, Inc. | NEW |
| Jun 4, 2004 | K041048 | POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE Internacional Farmaceutica, S.A. DE C.V. | NEW |
| Apr 13, 2004 | K040004 | ORTHOCORD SUTURE Depuy Mitek | NEW |
| Jul 17, 2003 | K031216 | MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE Aesculap | NEW |
| Jun 18, 2003 | K031443 | LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS Lsi Solutions | NEW |
| May 6, 2003 | K030786 | MONO-SWIFT Cp Medical | NEW |
| Mar 27, 2003 | K030212 | MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Biosurgery | NEW |
| Oct 9, 2002 | K022666 | PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. Arc Medical Supplies (Beijing) Co, Ltd. | NEW |
| Nov 16, 2001 | K013274 | MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE Cp Medical | NEW |
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