Kirwan Irrigation/Aspiration Handpiece
FDA 510(k) K930113 · Kirwan Surgical Products, Inc.
510(k) numberK930113
Submission
- Device name
- Kirwan Irrigation/Aspiration Handpiece
- Applicant
- Kirwan Surgical Products, Inc.
Rockland, MA, US - Received
- January 11, 1993
- Decision date
- February 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HMX – Cannula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
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|---|---|---|---|
| K010305 | Weiss Retinal CannulaHMX · Traditional | Micron Surgical, Inc. | 05/02/2001SE |
| K000457 | Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic…HMX · Traditional | Retinalabs.Com | 05/09/2000SE |
| K970873 | Endosoft Soft Tip Needle (20 Ga. and 19 Ga.)HMX · Traditional | American Medical Devices, Inc. | 05/20/1997SE |
| K943932 | Steriseal Ophthalmic CannulaHMX · Traditional | Pharma-Plast, Ltd. | 01/18/1995SE |
| K942403 | Infusion CannulaHMX · Traditional | Microsurgical Technology, Inc. | 08/17/1994SE |
| K934844 | Inter Tip THMX · Traditional | Microsurgical Technology, Inc. | 04/19/1994SE |
| K921488 | Aspirating Endo Ocular Probe W/IlluminationHMX · Traditional | Surgical Technologies, Inc. | 05/07/1992SE |
| K915074 | Irrigator/Aspirator ProbeHMX · Traditional | Biomedical Dynamics, Inc. | 02/05/1992SE |
| K904074 | Vitreoretinal Infusion CannulaHMX · Traditional | Visitec Co. | 02/26/1991SE |
| K901618 | Ocular Infusion Cannula SystemHMX · Traditional | Tamcenan Corp. | 05/31/1990SE |
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| K231872 | Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module…GEI · Traditional | 08/25/2023SE |
| K100912 | Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator…GXZ · Traditional | 08/19/2010SE |
| K070360 | Kirwan Disposable 23KHZ Manifold Tubing, 40-3600, & 36KHZ Manifold Tubing, 40-3601LFL · Traditional | 08/07/2007SE |
| K060915 | Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and AppliersHCH · Traditional | 04/17/2007SE |
| K062659 | Kirwan Disposable Battery-Powered Cautery, Model 41-61XX SeriesHQP · Traditional | 03/09/2007SE |
| K052203 | Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600GEI · Traditional | 10/20/2005SE |
| K023482 | Aura 20 Bipolar Electrosurgical Coagulator, Model 26-2500GEI · Traditional | 01/15/2003SE |
| K992218 | Disposable Irrigation Bipolar Cord Assembly for Malis System Cmc-Ii, Model 10-4601GEI · Traditional | 07/30/1999SE |
| K982176 | Kirwan Surgical Products, Inc. Model 28 1500 Electrosurgery GeneratorGEI · Traditional | 09/18/1998SE |
| K971341 | Kirwan Model 28 1000 Bipolar CoagulatorGEI · Traditional | 05/22/1997SE |
Questions and answers
When was Kirwan Irrigation/Aspiration Handpiece cleared by the FDA?
Kirwan Irrigation/Aspiration Handpiece (K930113) received a 510(k) decision of Substantially Equivalent on February 17, 1994, 402 days after the submission was received.
What is the product code of K930113?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.