Surgitron
FDA 510(k) K955158 · Ellman Intl., Inc.
510(k) numberK955158
Submission
- Device name
- Surgitron
- Applicant
- Ellman Intl., Inc.
Sound Beach, NY, US - Received
- November 13, 1995
- Decision date
- February 9, 1996
- 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 |
| 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 |
|---|---|---|
| K013255 | Surgitron 120 Iec (Also Known AS Surgitron 4.0 Dual RFGEI · Traditional | 11/07/2001SE |
| K003126 | Bipolar Trigger-Flex ProbeGEI · Traditional | 04/11/2001SE |
| K001986 | Surgitron Iec IIGEI · Traditional | 09/27/2000SE |
| K001407 | Surgitron Iec IIGEI · Traditional | 07/24/2000SE |
| K001253 | Surgitron Iec IIGEI · Traditional | 05/26/2000SE |
| K992382 | Surgitron RadiolaseGEI · Traditional | 10/14/1999SE |
| K990146 | SurgitronGEI · Traditional | 03/17/1999SE |
| K980177 | Sugitron Model: IecGEI · Traditional | 07/07/1998SE |
| K980170 | SurgitronGEI · Traditional | 06/29/1998SE |
| K972072 | Surgitron Model Ffpf-EmcGEI · Traditional | 06/19/1997SE |
Questions and answers
When was Surgitron cleared by the FDA?
Surgitron (K955158) received a 510(k) decision of Substantially Equivalent on February 9, 1996, 88 days after the submission was received.
What is the product code of K955158?
The FDA product code is HQR – Apparatus, Cautery, Radiofrequency, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4100.