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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Aesculap Inc MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM" Open, Classified |
HCF | None listed |
| Jan 31, 2024 | Aesculap Inc MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM"; Open, Classified |
HCF | None listed |
| May 9, 2023 | New Wave Endo-Surgical, Corp. M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall Terminated |
HCF | None listed |
| Nov 16, 2016 | Teleflex Medical Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites. Terminated |
HCF | None listed |
| Mar 24, 2016 | Teleflex Medical Weck EFx Classic Fascial Closure System, Rx Only, Sterile,
The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery Terminated |
HCF | None listed |
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