Hemstats
FDA 510(k) K844152 · I M, Inc.
510(k) numberK844152
Submission
- Device name
- Hemstats
- Applicant
- I M, Inc.
Fairfield, NJ, US - Received
- October 24, 1984
- Decision date
- November 7, 1984
- 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 |
| 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 |
|---|---|---|
| K914600 | Neurological SpongeHBA · Traditional | 12/30/1992SE |
| K892389 | Biopsy KitLRO · Traditional | 07/17/1989SESD |
| K881363 | Syringe Prefilled with WaterKOD · Traditional | 06/23/1988SE |
| K880753 | Umbilical Cord ClampHFW · Traditional | 04/27/1988SE |
| K872741 | NutripumpFRN · Traditional | 10/20/1987SE |
| K871495 | Bandages Catalog Number: 101 to 220NAD · Traditional | 05/08/1987SE |
| K863785 | Makler CatheterHDR · Traditional | 12/11/1986SE |
| K854155 | Sterile Saline SolutionKMJ · Traditional | 12/10/1985SE |
| K853287 | HuboutFPA · Traditional | 10/17/1985SE |
| K853288 | Feeding Units & TubesKNT · Traditional | 10/04/1985SE |
Questions and answers
When was Hemstats cleared by the FDA?
Hemstats (K844152) received a 510(k) decision of Substantially Equivalent on November 7, 1984, 14 days after the submission was received.
What is the product code of K844152?
The FDA product code is HRQ – Hemostat, a Class I (low risk) device regulated under 21 CFR 878.4800.