MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
FDA 510(k) clearance K942233 · decided 1994-07-01
Clearance details
- K-number
- K942233
- Device name
- MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
- Applicant
- Carl Zeiss, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-05-09
- Decision date
- 1994-07-01
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- EPT
- Device class
- 1
- Regulation number
- 878.4700
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Thornwood, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MICRODYNE OFFICE SURGICAL MICROSCOPE (K931284) | Microdyne, Inc. | 1993-11-18 |
| MICRINS CONTRAST BACKGROUND MATERIAL (K933310) | Micrins Surgical, Inc. | 1993-08-19 |
| STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. (K903412) | Storz Instrument Co. | 1990-09-20 |
| OPMI CS (K883581) | Carl Zeiss, Inc. | 1988-09-13 |
| STORZ DIAGNOSTIC MICROSCOPE SYSTEM (K882269) | Storz Instrument Co. | 1988-06-23 |
| ZEISS VOICE CONTROL SYSTEM FOR OPMI'S (K860811) | Carl Zeiss, Inc. | 1986-04-30 |
| STORZ/URBAN SURGICAL MICROSCOPE SYSTEM (K844858) | Storz Instrument Co. | 1985-03-25 |
| ELECTRONIC UNIT (K832887) | Surgi-Quip Inc.U | 1983-10-04 |
| VC III (K823011) | Teknar, Inc. | 1982-11-08 |
| MICROSCOPE (K822561) | Treace Medical, Inc. | 1982-09-14 |
| NAGASHIMA SU-A CEILING MOUNT UNIT FOR (K822014) | Kelleher Corp. | 1982-08-06 |
| BINOCULAR OPERATING MICROSCOPES & (K822009) | Kelleher Corp. | 1982-07-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS ND:YAG LASER (P850083/S008) | Carl Zeiss, Inc. | 1989-08-02 |
| VISULAS ND:YAG LASER (P850083/S007) | Carl Zeiss, Inc. | 1988-07-15 |
| VISULAS ND:YAG LASER (P850083/S006) | Carl Zeiss, Inc. | 1987-10-05 |
| VISULAS ND:YAG LASER (P850083/S005) | Carl Zeiss, Inc. | 1987-09-30 |
| VISULAS ND:YAG LASER (P850083/S004) | Carl Zeiss, Inc. | 1987-03-31 |
| VISULAS ND:YAG LASER (P850083/S001) | Carl Zeiss, Inc. | 1987-03-10 |
| VISULAS ND:YAG LASER (P850083/S003) | Carl Zeiss, Inc. | 1986-12-04 |