Microsurgical Keratome
FDA 510(k) K890216 · Kinetic Medical Products
510(k) numberK890216
Submission
- Device name
- Microsurgical Keratome
- Applicant
- Kinetic Medical Products
Erie, PA, US - Received
- January 18, 1989
- Decision date
- February 16, 1989
- 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 |
| 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 |
|---|---|---|
| K890385 | Midwifery/Obstetrical ForcepsHDA · Traditional | 03/01/1989SE |
| K890387 | Malleable Placenta CuretteHEX · Traditional | 02/27/1989SE |
| K890382 | Compression ForcepsHFW · Traditional | 02/27/1989SE |
| K890380 | Cervical Biopsy ForcepsHFB · Traditional | 02/27/1989SE |
| K890376 | Vaginal SpeculumHFD · Traditional | 02/27/1989SE |
| K890383 | Hysterectomy ForcepsHCZ · Traditional | 02/16/1989SE |
| K890389 | Umbilical ScissorsHDJ · Traditional | 02/13/1989SE |
| K890388 | Cephalotomy ScissorsKNB · Traditional | 02/13/1989SE |
| K890386 | Placenta and Ovum ForcepsHCZ · Traditional | 02/13/1989SE |
| K890384 | Uterine CuretteHCY · Traditional | 02/13/1989SE |
Questions and answers
When was Microsurgical Keratome cleared by the FDA?
Microsurgical Keratome (K890216) received a 510(k) decision of Substantially Equivalent on February 16, 1989, 29 days after the submission was received.
What is the product code of K890216?
The FDA product code is GZX – Instrument, Microsurgical, a Class I (low risk) device regulated under 21 CFR 882.4525.