Hemostat
FDA product code HRQ · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
15510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K920298 | Disposable HemostatsHRQ · Traditional | Falcon Instruments, Inc. | 08/11/1992SE |
| K895683 | Bernard Vessel ApproximatorHRQ · Traditional | Applied Medical Technologies | 10/24/1989SE |
| K890245 | Surgical HemostatsHRQ · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K884196 | Surgical Instruments (Various Types & Sizes)HRQ · Traditional | Disposable Sterile Surgical Instruments, Inc. | 11/08/1988SE |
| K881937 | Surgical InstrumentsHRQ · Traditional | Far East Intl. Trading Corp. | 06/15/1988SE |
| K861807 | Medcare Hemostats (Straight, Curved, Mosquito-Tip)HRQ · Traditional | Medcomp Technologies, Inc. | 05/23/1986SE |
| K844152 | HemstatsHRQ · Traditional | I M, Inc. | 11/07/1984SE |
| K843593 | Surgipress Surgical LoopHRQ · Traditional | Syntex Corp. | 10/24/1984SE |
| K841514 | Scanlan Vascu-Statt II ApproximatorHRQ · Traditional | Scanlan Intl., Inc. | 06/05/1984SE |
| K834175 | Op-Con Surg. Instruments #11HRQ · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
| K831797 | HemostatsHRQ · Traditional | I M, Inc. | 07/19/1983SE |
| K823694 | Vascu-Statt ApproximatorHRQ · Traditional | Scanlan Intl., Inc. | 01/07/1983SE |
| K822263 | Various Types of Tonsils HemostatsHRQ · Traditional | Kelleher Corp. | 08/16/1982SE |
| K821887 | Scanlan Suture-StattHRQ · Traditional | Scanlan Intl., Inc. | 07/28/1982SE |
| K821617 | Disposable HemostatsHRQ · Traditional | Medcare Products | 06/21/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1309-2025 Class II | Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps…The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Aesculap Inc | 01/31/2025Open, Classified |
| Z-0754-2025 Class II | STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to… | MEDLINE INDUSTRIES, LP - Northfield | 11/12/2024Open, Classified |
| Z-1438-2024 Class II | Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |