Olympus FG Series of Rat Tooth Grasping Forceps
FDA 510(k) K955051 · Olympus America, Inc.
510(k) numberK955051
Submission
- Device name
- Olympus FG Series of Rat Tooth Grasping Forceps
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- November 6, 1995
- Decision date
- January 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
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Questions and answers
When was Olympus FG Series of Rat Tooth Grasping Forceps cleared by the FDA?
Olympus FG Series of Rat Tooth Grasping Forceps (K955051) received a 510(k) decision of Substantially Equivalent on January 18, 1996, 73 days after the submission was received.
What is the product code of K955051?
The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.