Return Path Diathermy Handle
FDA 510(k) K941495 · Mira, Inc.
510(k) numberK941495
Submission
- Device name
- Return Path Diathermy Handle
- Applicant
- Mira, Inc.
North Attleboro, MA, US - Received
- March 28, 1994
- Decision date
- July 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
| 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 |
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| K933527 | Modification of Anterior Segment ElectrodesHWA · Traditional | 01/25/1994SE |
| K923629 | Ophthalmic Trichiasis ProbeHPS · Traditional | 10/19/1992SE |
| K894248 | Converter SystemHQE · Traditional | 02/27/1990SE |
| K891601 | Power Operated and Controlled Vitreous ScissorsHQE · Traditional | 05/23/1989SE |
| K890448 | Light Source, Endoscop, Xenon ArcFFS · Traditional | 05/08/1989SE |
| K863246 | MiraliteHQF · Traditional | 10/31/1986SE |
| K863591 | Endophotocoagulation ProbeHQF · Traditional | 10/10/1986SE |
| K855105 | Simmons ShellHQT · Traditional | 03/31/1986SE |
Questions and answers
When was Return Path Diathermy Handle cleared by the FDA?
Return Path Diathermy Handle (K941495) received a 510(k) decision of Substantially Equivalent on July 15, 1994, 109 days after the submission was received.
What is the product code of K941495?
The FDA product code is HQR – Apparatus, Cautery, Radiofrequency, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4100.