ERBECRYO 2 Cryosurgical Unit with accessories
FDA 510(k) K151041 · Erbe USA, Inc.
510(k) numberK151041
Submission
- Device name
- ERBECRYO 2 Cryosurgical Unit with accessories
- Applicant
- Erbe USA, Inc.
Marietta, GA, US - Received
- April 20, 2015
- Decision date
- May 4, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
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Questions and answers
When was ERBECRYO 2 Cryosurgical Unit with accessories cleared by the FDA?
ERBECRYO 2 Cryosurgical Unit with accessories (K151041) received a 510(k) decision of Substantially Equivalent on May 4, 2015, 14 days after the submission was received.
What is the product code of K151041?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.