Panels › General, Plastic Surgery › Product code HCF · Class 1
Instrument, Ligature Passing And Knot Tying
Regulation 878.4800
0510(k)s in 12 months (5 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in HCF
| Company | 510(k)s | Recalls |
|---|---|---|
| Aesculap Inc | 0 | 2 |
| Teleflex Medical | 0 | 2 |
| Boston Scientific Corp | 1 | 0 |
| Davis & Geck, Inc. | 1 | 0 |
| Edwards Lifesciences, LLC | 1 | 0 |
| J. Sklar Mfg. Co., Inc. | 1 | 0 |
| New Wave Endo-Surgical, Corp. | 0 | 1 |
| Plastafil, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 16, 2015 | K150882 | Edwards Suture Fastening System Edwards Lifesciences, LLC | HCF |
| Jul 13, 1993 | K931379 | MICROVASIVE INSURG LAPTIE SUTURE LIGATOR Boston Scientific Corp | HCF |
| Jun 12, 1985 | K851452 | VALTRAC PURSESTING DEVICE Davis & Geck, Inc. | HCF |
| Aug 27, 1984 | K841617 | STROVER HOOK Plastafil, Inc. | HCF |
| Apr 23, 1979 | K790577 | HEMORRHOIDAL LIGATOR J. Sklar Mfg. Co., Inc. | HCF |
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