Vickers Ergomatic Micros Instr-Long R or L Handed
FDA 510(k) K853180 · Keeler Instruments, Inc.
510(k) numberK853180
Submission
- Device name
- Vickers Ergomatic Micros Instr-Long R or L Handed
- Applicant
- Keeler Instruments, Inc.
Broomall, PA, US - Received
- July 30, 1985
- Decision date
- October 28, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GZX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932169 | Microsurgical InstrumentsGZX · Traditional | American Russian Medical Services, Inc. | 07/20/1993SE |
| K926048 | Clarus Endoscopic Ball ProbeGZX · Traditional | Clarus Medical Systems, Inc. | 04/07/1993SE |
| K911932 | J105 James Surgical System I/A PackGZX · Traditional | O.R. Specialties, Inc. | 08/26/1991SE |
| K890216 | Microsurgical KeratomeGZX · Traditional | Kinetic Medical Products | 02/16/1989SE |
| K873934 | Range of Crocodile Action InstrumentsGZX · Traditional | Downs Surgical , Ltd. | 12/17/1987SE |
| K873933 | Range of Neurosurgical Instruments in TitaniumGZX · Traditional | Downs Surgical , Ltd. | 12/17/1987SE |
| K862971 | Micra Microsurgical InstrumentsGZX · Traditional | Cordis Corp. | 08/25/1986SE |
| K853179 | Vickers Ergomatic Microsur Instru-Univ R O L HandGZX · Traditional | Keeler Instruments, Inc. | 11/07/1985SE |
| K853161 | The Vickers Standard Microsurgery SetGZX · Traditional | Keeler Instruments, Inc. | 11/07/1985SE |
| K853181 | Vickers Ergomatic Micros Instr-Fine R or L HandedGZX · Traditional | Keeler Instruments, Inc. | 10/28/1985SE |
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| K100500 | PSL Classic Slit LampHJO · Traditional | 03/09/2010SE |
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| K060822 | Vantage Indirect OphthalmoscopeHLI · Special | 05/23/2006SE |
| K032087 | Keeler Wide Angle Ophthalmoscope Model 1130-P-5004HLJ · Traditional | 11/26/2003SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | 12/21/1999SE |
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Questions and answers
When was Vickers Ergomatic Micros Instr-Long R or L Handed cleared by the FDA?
Vickers Ergomatic Micros Instr-Long R or L Handed (K853180) received a 510(k) decision of Substantially Equivalent on October 28, 1985, 90 days after the submission was received.
What is the product code of K853180?
The FDA product code is GZX – Instrument, Microsurgical, a Class I (low risk) device regulated under 21 CFR 882.4525.