Product code FSQ
- Device name
- Light, Surgical, Instrument
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4580
- 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 |
|---|---|---|---|
| K930686 | MIDMARK SURGICAL LIGHTING SYSTEMS | Midmark Corp. | 1993-07-30 |
| K932139 | LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT | Aaron Medical Industries | 1993-07-30 |
| K922409 | ALM ILLUMINATOR SERIES LIGHT SYSTEM | Alm Surgical Equipment, Inc. | 1993-01-12 |
| K921848 | BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT | Alm Surgical Equipment, Inc. | 1992-10-01 |
| K803067 | SURG-FLEX 10 LIGHT | Medical Products Development, Inc. | 1981-02-26 |
| K810018 | SURG-FLEX 5 SURGICAL LIGHT | Medical Products Development, Inc. | 1981-01-23 |
| K810019 | SURG-FLEX 15 SURGICAL LIGHT | Medical Products Development, Inc. | 1981-01-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00887761967250 | Sterilizable Handles | Baxter Medical Systems GmbH + Co. KG | 2023-07-11 |
| 00887761967274 | Sterilizable Handles | Baxter Medical Systems GmbH + Co. KG | 2023-06-26 |
| 00887761968325 | iLED7 Surgical Light | Baxter Medical Systems GmbH + Co. KG | 2023-01-05 |
| 00887761968288 | iLED7 Surgical Light | Baxter Medical Systems GmbH + Co. KG | 2023-01-05 |
| 00887761968271 | iLED7 Surgical Light | Baxter Medical Systems GmbH + Co. KG | 2022-12-15 |
| 00887761968134 | Pre-Install Set | Baxter Medical Systems GmbH + Co. KG | 2022-12-15 |
| 00887761968127 | Pre-Install Set | Baxter Medical Systems GmbH + Co. KG | 2022-12-15 |
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| 10705034358994 | SPOTLIGHT | DEPUY SPINE, LLC | 2016-06-30 |
| 10705034359380 | SPOTLIGHT | DEPUY SPINE, LLC | 2016-06-30 |
| 10705034359359 | SPOTLIGHT | DEPUY SPINE, LLC | 2016-06-30 |
| 10705034359298 | SPOTLIGHT | DEPUY SPINE, LLC | 2016-06-30 |
| 10705034359168 | SPOTLIGHT | DEPUY SPINE, LLC | 2016-06-30 |
| 10705034359106 | SPOTLIGHT | DEPUY SPINE, LLC | 2016-06-30 |
| 10705034359007 | SPOTLIGHT | DEPUY SPINE, LLC | 2016-06-30 |