Disposable Hemostats
FDA 510(k) K821617 · Medcare Products
510(k) numberK821617
Submission
- Device name
- Disposable Hemostats
- Applicant
- Medcare Products
Mchenry, IL, US - Received
- June 2, 1982
- Decision date
- June 21, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HRQ – Hemostat
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HRQ
| 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 |
More from Imm Enterprises , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K841122 | Tracheostomy Care TrayFSM · Traditional | 04/25/1984SE |
| K841124 | Dialysis TrayKOC · Traditional | 04/20/1984SE |
| K841123 | Dressing Change TrayFRG · Traditional | 04/17/1984SE |
| K831374 | Med Care Prep Razor · Traditional | 10/04/1983SE |
| K831663 | Tissue ForcepsKOC · Traditional | 09/26/1983SE |
| K831665 | Disposable Needle HolderKDC · Traditional | 09/12/1983SE |
| K831664 | Plastic Thumb ForcepsKDC · Traditional | 09/12/1983SE |
| K831661 | Disposable ScissorsKDC · Traditional | 08/25/1983SE |
| K831662 | Disposable Hemostat (Straight&CurvedKDC · Traditional | 07/19/1983SE |
| K823854 | Medcare Suture Removal TraysFSM · Traditional | 03/31/1983SE |
Questions and answers
When was Disposable Hemostats cleared by the FDA?
Disposable Hemostats (K821617) received a 510(k) decision of Substantially Equivalent on June 21, 1982, 19 days after the submission was received.
What is the product code of K821617?
The FDA product code is HRQ – Hemostat, a Class I (low risk) device regulated under 21 CFR 878.4800.