Refractec MCS-100
FDA 510(k) K980522 · Refractec, Inc.
510(k) numberK980522
Submission
- Device name
- Refractec MCS-100
- Applicant
- Refractec, Inc.
Laguna Hills, CA, US - Received
- February 10, 1998
- Decision date
- July 22, 1998
- Decision
- Unknown (SESU)
- 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 |
| 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 |
| K934320 | Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion AspirationHQR · Traditional | Mentor O & O, Inc. | 02/16/1994SE |
| 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 |
|---|---|---|
| K053475 | Optipoint Corneal Marker, Model VPT-OPT-450HMR · Traditional | 03/03/2006SE |
Questions and answers
When was Refractec MCS-100 cleared by the FDA?
Refractec MCS-100 (K980522) received a 510(k) decision of Unknown on July 22, 1998, 162 days after the submission was received.
What is the product code of K980522?
The FDA product code is HQR – Apparatus, Cautery, Radiofrequency, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4100.