Product code EPT
- Device name
- Microscope, Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4700
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942233 | MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM | Carl Zeiss, Inc. | 1994-07-01 |
| K931284 | MICRODYNE OFFICE SURGICAL MICROSCOPE | Microdyne, Inc. | 1993-11-18 |
| K933310 | MICRINS CONTRAST BACKGROUND MATERIAL | Micrins Surgical, Inc. | 1993-08-19 |
| K903412 | STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. | Storz Instrument Co. | 1990-09-20 |
| K883581 | OPMI CS | Carl Zeiss, Inc. | 1988-09-13 |
| K882269 | STORZ DIAGNOSTIC MICROSCOPE SYSTEM | Storz Instrument Co. | 1988-06-23 |
| K860811 | ZEISS VOICE CONTROL SYSTEM FOR OPMI'S | Carl Zeiss, Inc. | 1986-04-30 |
| K844858 | STORZ/URBAN SURGICAL MICROSCOPE SYSTEM | Storz Instrument Co. | 1985-03-25 |
| K832887 | ELECTRONIC UNIT | Surgi-Quip Inc.U | 1983-10-04 |
| K823011 | VC III | Teknar, Inc. | 1982-11-08 |
| K822561 | MICROSCOPE | Treace Medical, Inc. | 1982-09-14 |
| K822014 | NAGASHIMA SU-A CEILING MOUNT UNIT FOR | Kelleher Corp. | 1982-08-06 |
| K822009 | BINOCULAR OPERATING MICROSCOPES & | Kelleher Corp. | 1982-07-30 |
| K821689 | LEBANON MICROSCOPE | The Lebanon Corp. | 1982-07-09 |
| K812234 | STORZ/OLYMPUS MICROSCOPE SYSTEM | Storz Instrument Co. | 1981-09-11 |
| K802904 | MICROSCOPE MODEL OM-U | Jedmed Instrument Co. | 1981-02-04 |
| K802903 | MICROSCOPE MODEL OM-P | Jedmed Instrument Co. | 1981-02-04 |
| K760696 | REMOTE CONTROL SYSTEM FOR MICROSCOPE | Alcon Laboratories | 1976-12-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860014850509 | HMDmd Wearable Surgical Monitor | HMDMD INC. | 2025-11-22 |
| 07630003501629 | M320 Optics Carrier | Leica Microsystems (Schweiz) AG | 2025-10-22 |
| 07630003501636 | M320 Optics Carrier | Leica Microsystems (Schweiz) AG | 2025-10-22 |
| 07630003501643 | M320 Optics Carrier | Leica Microsystems (Schweiz) AG | 2025-10-22 |
| 07630003501421 | M320 Optics Carrier | Leica Microsystems (Schweiz) AG | 2025-10-22 |
| 00840183528461 | BR Surgical, LLC | BR Surgical, LLC | 2024-11-07 |
| 00850047802002 | Prescott’s Wall Mount Surgical Microscope Platform | Prescott's Inc. | 2024-02-22 |
| 00850047802019 | OSM200 Stand | Prescott's Inc. | 2024-02-22 |
| 00860009669161 | SEILER MEDICAL DIVISION | SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED | 2022-12-13 |
| 00860009669178 | SEILER MEDICAL DIVISION | SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED | 2022-12-13 |
| 00860009669154 | SEILER MEDICAL DIVISION | SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED | 2022-12-13 |
| 00860009669147 | SEILER MEDICAL DIVISION | SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED | 2022-12-13 |
| 00860009669123 | SEILER MEDICAL DIVISION | SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED | 2022-12-12 |
| 00860009669116 | SEILER MEDICAL DIVISION | SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED | 2022-12-12 |
| 00860009669109 | SEILER MEDICAL DIVISION | SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED | 2022-12-12 |
| 00860009669130 | SEILER MEDICAL DIVISION | SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED | 2022-12-12 |
| U1OM200WLRX1 | MICROSCOPE | Ecleris | 2022-07-29 |
| U1OM200WRX1 | MICROSCOPE | Ecleris | 2022-07-18 |
| 04048551321553 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551318171 | MICROCAST | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551313572 | POINT SETTER | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551255896 | POINT SETTER | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551243466 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551221723 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 02618125142512 | TIDIShield | TIDI PRODUCTS, LLC | 2017-03-31 |
| 01618125142483 | TIDIShield | TIDI PRODUCTS, LLC | 2017-03-31 |
| 02618125177576 | SteriGear | TIDI PRODUCTS, LLC | 2017-03-29 |
| 02618125177903 | Thea Surgical | TIDI PRODUCTS, LLC | 2017-01-24 |
| 01618125177089 | Drapetech | TIDI PRODUCTS, LLC | 2016-12-09 |
| 01618125175702 | Drapetech | TIDI PRODUCTS, LLC | 2016-12-08 |