Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion Aspiration
FDA 510(k) K934320 · Mentor O & O, Inc.
510(k) numberK934320
Submission
- Device name
- Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion Aspiration
- Applicant
- Mentor O & O, Inc.
Norwell, MA, US - Received
- September 3, 1993
- Decision date
- February 16, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQR – Apparatus, Cautery, Radiofrequency, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4100
- Specialty
- Ophthalmic
Other 510(k)s with product code HQR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050308 | Thermal Cautery ProbeHQR · Special | Starion Instruments | 02/25/2005SE |
| K990064 | Di-Rhex Ophthalmic Diathermy SystemHQR · Traditional | Ophthalmic Technologies, Inc. | 04/04/1999SE |
| K980522 | Refractec MCS-100HQR · Traditional | Refractec, Inc. | 07/22/1998SESU |
| K972749 | Pao Bipolar Coaxial Coagulator (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)HQR · Traditional | C.M. Chance , Ltd. | 03/13/1998SE |
| K952151 | Storz Ophthalmic Bipolar Cautery Instruments (D8200, D8201, D8203) and Bipolar Cords…HQR · Traditional | Storz | 03/04/1996SE |
| K955158 | SurgitronHQR · Traditional | Ellman Intl., Inc. | 02/09/1996SE |
| K952569 | Gamp & Associates Three Function Disposable ManipulatorHQR · Traditional | Gamp & Assoc. | 01/05/1996SE |
| K941495 | Return Path Diathermy HandleHQR · Traditional | Mira, Inc. | 07/15/1994SE |
| K895800 | Advanced Surgical Solid State Bipolar CoagulatorHQR · Traditional | Advanced Surgical Products, Inc. | 01/22/1990SE |
| K870194 | United Surgical Corp. Diathermic PlusHQR · Traditional | United Surgical Corp. | 02/20/1987SE |
More from United Surgical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K955245 | Mentor Meridian Phacoemulsification SystemHQC · Traditional | 02/12/1996SE |
| 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 |
| K903878 | Mentor(R) Durastat(Tm) Autoclav Bipolar HemostatHQQ · Traditional | 11/05/1990SE |
| 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 Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion Aspiration cleared by the FDA?
Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion Aspiration (K934320) received a 510(k) decision of Substantially Equivalent on February 16, 1994, 166 days after the submission was received.
What is the product code of K934320?
The FDA product code is HQR – Apparatus, Cautery, Radiofrequency, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4100.