Hummer Trak System
FDA 510(k) K990038 · Stryker Endoscopy
510(k) numberK990038
Submission
- Device name
- Hummer Trak System
- Applicant
- Stryker Endoscopy
Santa Clara, CA, US - Received
- January 6, 1999
- Decision date
- February 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4250
- Specialty
- Ear, Nose, Throat
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Questions and answers
When was Hummer Trak System cleared by the FDA?
Hummer Trak System (K990038) received a 510(k) decision of Substantially Equivalent on February 19, 1999, 44 days after the submission was received.
What is the product code of K990038?
The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.