Storz Model 62 ENT Camera System
FDA 510(k) K883760 · Storz Instrument Co.
510(k) numberK883760
Submission
- Device name
- Storz Model 62 ENT Camera System
- Applicant
- Storz Instrument Co.
St. Louis, MO, US - Received
- September 6, 1988
- Decision date
- September 28, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FWL – Camera, Cine, Endoscopic, Without Audio
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FWL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951519 | Weco Endoscopic System with Fiber Optic LightFWL · Traditional | Wells Johnson Co. | 06/14/1995SE |
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| K971439 | Storz Microflow and Storz Standard Phacoemulsification NeedlesHQC · Traditional | 06/17/1997SE |
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| K960024 | Storz D7120 Phaco Handpiece Maintenance Kit & Storz D7125 Phaco Handpiece Needle WrenchHQC · Traditional | 09/20/1996SE |
| K960061 | Storz D7108 Microscissors Handpiece/Storz D7106 Microscissors Drive TubeHQE · Traditional | 09/18/1996SE |
| K960003 | Storz D7116 Microvit Vitrectomy Cutter ExtensionHQC · Traditional | 08/29/1996SE |
| K962131 | Storz D4600 Air Exchange Line PackHQC · Traditional | 08/23/1996SE |
| K961874 | Storz DP5100 Anterior Collection Cassette PackHQC · Traditional | 08/06/1996SE |
Questions and answers
When was Storz Model 62 ENT Camera System cleared by the FDA?
Storz Model 62 ENT Camera System (K883760) received a 510(k) decision of Substantially Equivalent on September 28, 1988, 22 days after the submission was received.
What is the product code of K883760?
The FDA product code is FWL – Camera, Cine, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.