Stryker Hummer II Microdebrider System
FDA 510(k) K952681 · Stryker Endoscopy
510(k) numberK952681
Submission
- Device name
- Stryker Hummer II Microdebrider System
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- June 12, 1995
- Decision date
- July 20, 1995
- 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 Stryker Hummer II Microdebrider System cleared by the FDA?
Stryker Hummer II Microdebrider System (K952681) received a 510(k) decision of Substantially Equivalent on July 20, 1995, 38 days after the submission was received.
What is the product code of K952681?
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.