Mehta Bronchial Biospy Drill
FDA 510(k) K954693 · United States Endoscopy Group, Inc.
510(k) numberK954693
Submission
- Device name
- Mehta Bronchial Biospy Drill
- Applicant
- United States Endoscopy Group, Inc.
Mentor, OH, US - Received
- October 11, 1995
- Decision date
- October 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCK – Instrument, Biopsy, Suction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Mehta Bronchial Biospy Drill cleared by the FDA?
Mehta Bronchial Biospy Drill (K954693) received a 510(k) decision of Substantially Equivalent on October 23, 1995, 12 days after the submission was received.
What is the product code of K954693?
The FDA product code is FCK – Instrument, Biopsy, Suction, a Class II (moderate risk) device regulated under 21 CFR 876.1075.