Advanced Surgical Solid State Bipolar Coagulator
FDA 510(k) K895800 · Advanced Surgical Products, Inc.
510(k) numberK895800
Submission
- Device name
- Advanced Surgical Solid State Bipolar Coagulator
- Applicant
- Advanced Surgical Products, Inc.
Chesterfield, MO, US - Received
- September 28, 1989
- Decision date
- January 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
| K934320 | Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion AspirationHQR · Traditional | Mentor O & O, Inc. | 02/16/1994SE |
| K870194 | United Surgical Corp. Diathermic PlusHQR · Traditional | United Surgical Corp. | 02/20/1987SE |
More from United Surgical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K030926 | Fast Throw Stainless Steel Surgical SutureFZP · Traditional | 07/21/2003SE |
| K896754 | I/A HandpieceHQE · Traditional | 01/11/1990SE |
| K896305 | Multi-Use I/A HandpieceHQE · Traditional | 12/18/1989SE |
| K884557 | Advanced Surgical Products Scissors HandpieceHQE · Traditional | 05/12/1989SE |
| K884556 | Dreyer Curved EndoilluminatorHQE · Traditional | 02/28/1989SE |
| K890398 | Ryan-Style Directed Infusion ManipulatorHBI · Traditional | 02/17/1989SE |
| K884347 | Modified Disposable Coaxial Bipolar PenGXI · Traditional | 12/27/1988SE |
| K883858 | Fiberoptic Sharp Integral Pick LightpipeHBI · Traditional | 09/29/1988SE |
| K883857 | Fiberoptic Wire Pick LightpipeHBI · Traditional | 09/29/1988SE |
| K883856 | Fiberoptic Blunt Integral Pick LightpipeHBI · Traditional | 09/29/1988SE |
Questions and answers
When was Advanced Surgical Solid State Bipolar Coagulator cleared by the FDA?
Advanced Surgical Solid State Bipolar Coagulator (K895800) received a 510(k) decision of Substantially Equivalent on January 22, 1990, 116 days after the submission was received.
What is the product code of K895800?
The FDA product code is HQR – Apparatus, Cautery, Radiofrequency, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4100.