Clarus Endoscopic Ball Probe
FDA 510(k) K926048 · Clarus Medical Systems, Inc.
510(k) numberK926048
Submission
- Device name
- Clarus Endoscopic Ball Probe
- Applicant
- Clarus Medical Systems, Inc.
Minneapolis, MN, US - Received
- December 1, 1992
- Decision date
- April 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K853180 | Vickers Ergomatic Micros Instr-Long R or L HandedGZX · Traditional | Keeler Instruments, Inc. | 10/28/1985SE |
More from Keeler Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980588 | Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional | 08/18/1998SE |
| K974579 | Percscope Model 2600HRX · Traditional | 02/18/1998SE |
| K971584 | Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series)OCV · Traditional | 05/23/1997SE |
| K971455 | Clarus Model 5197 SightliteFTI · Traditional | 05/20/1997SE |
| K960915 | Clarus Neuropen Endoscopic Placement Kit Model 2125-XXXGWG · Traditional | 12/24/1996SE |
| K962255 | Clarus Murphypen ENDOSCOPE(2127-XXX)EOB · Traditional | 09/11/1996SE |
| K955598 | Clarus Spinepen Model 2126GWG · Traditional | 02/06/1996SE |
| K953685 | Instrument ScopeGWG · Traditional | 10/12/1995SE |
| K945633 | Neuro Channel Endoscope Model 2232GWG · Traditional | 09/19/1995SE |
| K945296 | Clarus Phoenix Neuro Endoscope Model 2160GWG · Traditional | 07/14/1995SE |
Questions and answers
When was Clarus Endoscopic Ball Probe cleared by the FDA?
Clarus Endoscopic Ball Probe (K926048) received a 510(k) decision of Substantially Equivalent on April 7, 1993, 127 days after the submission was received.
What is the product code of K926048?
The FDA product code is GZX – Instrument, Microsurgical, a Class I (low risk) device regulated under 21 CFR 882.4525.