BINOCULAR OPERATING MICROSCOPES &
FDA 510(k) clearance K822009 · decided 1982-07-30
Clearance details
- K-number
- K822009
- Device name
- BINOCULAR OPERATING MICROSCOPES &
- Applicant
- Kelleher Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-08
- Decision date
- 1982-07-30
- Days to decision
- 22 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
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kelleher Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM (K942233) | Carl Zeiss, Inc. | 1994-07-01 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.