Scanlan Vascu-Statt II
FDA 510(k) K841515 · Scanlan Intl., Inc.
510(k) numberK841515
Submission
- Device name
- Scanlan Vascu-Statt II
- Applicant
- Scanlan Intl., Inc.
Mchenry, IL, US - Received
- April 12, 1984
- Decision date
- June 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HRG – Engine, Trephine, Accessories, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4070
- Specialty
- Ophthalmic
Other 510(k)s with product code HRG
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|---|---|---|---|
| K013151 | Asmotom Automated Trephine SystemHRG · Traditional | Bkg Opthalmics USA, Inc. | 12/14/2001SE |
| K981063 | Automated Corneal TrephineHRG · Traditional | Laser Center Dev. Corp. | 06/23/1998SE |
| K843957 | Ultrathin/Sp LensHRG · Traditional | Optical Systems Intl., Inc. | 07/31/1985SE |
| K823901 | Trephine Blades-Various ModelsHRG · Traditional | Edward Weck, Inc. | 01/17/1983SE |
| K791763 | (Micro-Keratron, Micro Duct Trephine)HRG · Traditional | Intl. Ophthalmic Industries Corp. | 11/05/1979SE |
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| 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 |
| K841514 | Scanlan Vascu-Statt II ApproximatorHRQ · Traditional | 06/05/1984SE |
Questions and answers
When was Scanlan Vascu-Statt II cleared by the FDA?
Scanlan Vascu-Statt II (K841515) received a 510(k) decision of Substantially Equivalent on June 5, 1984, 54 days after the submission was received.
What is the product code of K841515?
The FDA product code is HRG – Engine, Trephine, Accessories, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4070.