Mentor(R) Durastat(Tm) Autoclav Bipolar Hemostat
FDA 510(k) K903878 · Mentor O & O, Inc.
510(k) numberK903878
Submission
- Device name
- Mentor(R) Durastat(Tm) Autoclav Bipolar Hemostat
- Applicant
- Mentor O & O, Inc.
Norwell, MA, US - Received
- August 22, 1990
- Decision date
- November 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQQ – Apparatus, Cautery, Radiofrequency, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4100
- Specialty
- Ophthalmic
Other 510(k)s with product code HQQ
More from Mentor O & O, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955245 | Mentor Meridian Phacoemulsification SystemHQC · Traditional | 02/12/1996SE |
| K934320 | Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion AspirationHQR · Traditional | 02/16/1994SE |
| K912904 | Mentor Odyssey Phacoemulsification SystemHQC · Traditional | 06/11/1992SE |
| K915340 | Mentor Horizon Low Vision MagnifierHJG · Traditional | 03/30/1992SE |
| K910637 | Mentor(R) Sur-E-Trol(R)FRN · Traditional | 05/13/1991SE |
| K911160 | Mentor(R) Wet-Field(R) II Ac Coagulator, 22-1305GEI · Traditional | 05/02/1991SE |
| K895010 | Mentor Spectacle Binocular Indirect OphthalmoscopeHLI · Traditional | 09/11/1989SE |
| K890622 | Surg-E-Trol System I and System IIHQE · Traditional | 05/04/1989SE |
| K890595 | Mentor Anterior Segment VitrectorHKP · Traditional | 04/17/1989SE |
| K881001 | Mentor Wet-Field*Ii CoagulatorHQQ · Traditional | 05/13/1988SE |
Questions and answers
When was Mentor(R) Durastat(Tm) Autoclav Bipolar Hemostat cleared by the FDA?
Mentor(R) Durastat(Tm) Autoclav Bipolar Hemostat (K903878) received a 510(k) decision of Substantially Equivalent on November 5, 1990, 75 days after the submission was received.
What is the product code of K903878?
The FDA product code is HQQ – Apparatus, Cautery, Radiofrequency, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4100.