Endoscopic Retrieval Device
FDA 510(k) K120084 · United States Endoscopy Group, Inc.
510(k) numberK120084
Submission
- Device name
- Endoscopic Retrieval Device
- Applicant
- United States Endoscopy Group, Inc.
Mentor, OH, US - Received
- January 11, 2012
- Decision date
- May 30, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Endoscopic Retrieval Device cleared by the FDA?
Endoscopic Retrieval Device (K120084) received a 510(k) decision of Substantially Equivalent on May 30, 2012, 140 days after the submission was received.
What is the product code of K120084?
The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.