Medcare Hemostats (Straight, Curved, Mosquito-Tip)
FDA 510(k) K861807 · Medcomp Technologies, Inc.
510(k) numberK861807
Submission
- Device name
- Medcare Hemostats (Straight, Curved, Mosquito-Tip)
- Applicant
- Medcomp Technologies, Inc.
Penfield, NY, US - Received
- May 9, 1986
- Decision date
- May 23, 1986
- 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 |
| 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 |
More from I M, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861806 | Medcare Suture Scissors (Suture/Gauze Weight)KDA · Traditional | 05/23/1986SE |
| K861805 | Medcare Forceps (Thumb, Tissue)GEN · Traditional | 05/23/1986SE |
| K861804 | Medcare Suture Removal Kit · Traditional | 05/23/1986SE |
| K860683 | Medcare Emergency Shears/Punch & Fin Tips · Traditional | 03/13/1986SE |
Questions and answers
When was Medcare Hemostats (Straight, Curved, Mosquito-Tip) cleared by the FDA?
Medcare Hemostats (Straight, Curved, Mosquito-Tip) (K861807) received a 510(k) decision of Substantially Equivalent on May 23, 1986, 14 days after the submission was received.
What is the product code of K861807?
The FDA product code is HRQ – Hemostat, a Class I (low risk) device regulated under 21 CFR 878.4800.