MOLLI 2 System
FDA 510(k) K253888 · Stryker Endoscopy
510(k) numberK253888
Submission
- Device name
- MOLLI 2 System
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- December 4, 2025
- Decision date
- December 31, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was MOLLI 2 System cleared by the FDA?
MOLLI 2 System (K253888) received a 510(k) decision of Substantially Equivalent on December 31, 2025, 27 days after the submission was received.
What is the product code of K253888?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.