Pneumatic Cutter System
FDA 510(k) K983050 · Surgical Laser Technologies, Inc.
510(k) numberK983050
Submission
- Device name
- Pneumatic Cutter System
- Applicant
- Surgical Laser Technologies, Inc.
Montgomeryville, PA, US - Received
- September 1, 1998
- Decision date
- November 25, 1998
- 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 Pneumatic Cutter System cleared by the FDA?
Pneumatic Cutter System (K983050) received a 510(k) decision of Substantially Equivalent on November 25, 1998, 85 days after the submission was received.
What is the product code of K983050?
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.