Vascu-Statt Approximator
FDA 510(k) K823694 · Scanlan Intl., Inc.
510(k) numberK823694
Submission
- Device name
- Vascu-Statt Approximator
- Applicant
- Scanlan Intl., Inc.
Mchenry, IL, US - Received
- December 8, 1982
- Decision date
- January 7, 1983
- 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 |
|---|---|---|
| K960372 | Scanlan Heifetz Aneurysm Elgiloy Clip SystemHCH · Traditional | 04/26/1996SE |
| K945474 | Scanlan(R) Thoracoscopic Scissors, Clamp, Forceps, Needle HolderGCJ · Traditional | 12/05/1994SE |
| K911184 | Scanlan/Taheri ValvulotomeMGZ · Traditional | 02/18/1992SE |
| K864920 | Scanlan (TM) Instrument TrayFSM · Traditional | 01/12/1987SE |
| K864919 | Scanlan (TM) Vein/Graft HolderKPK · Traditional | 01/12/1987SE |
| K851825 | Scanlan Tunneler, Sheath & TipDWS · Traditional | 07/12/1985SE |
| K841521 | Scanlan EndarsectorDWX · Traditional | 08/03/1984SE |
| K841513 | Scanlan Atraum Instrument Jaw Cover · Traditional | 07/06/1984SE |
| K841085 | Scanlan Colormark Skin MarkerFZZ · Traditional | 06/11/1984SE |
| K841515 | Scanlan Vascu-Statt IIHRG · Traditional | 06/05/1984SE |
Questions and answers
When was Vascu-Statt Approximator cleared by the FDA?
Vascu-Statt Approximator (K823694) received a 510(k) decision of Substantially Equivalent on January 7, 1983, 30 days after the submission was received.
What is the product code of K823694?
The FDA product code is HRQ – Hemostat, a Class I (low risk) device regulated under 21 CFR 878.4800.