Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch
FDA 510(k) K991960 · Stryker Endoscopy
510(k) numberK991960
Submission
- Device name
- Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch
- Applicant
- Stryker Endoscopy
Santa Clara, CA, US - Received
- June 10, 1999
- Decision date
- August 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch cleared by the FDA?
Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch (K991960) received a 510(k) decision of Substantially Equivalent on August 13, 1999, 64 days after the submission was received.
What is the product code of K991960?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.