MOLLI 2 System
FDA 510(k) clearance K253888 · decided 2025-12-31
Clearance details
- K-number
- K253888
- Device name
- MOLLI 2 System
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 2025-12-04
- Decision date
- 2025-12-31
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- NEU
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stryker Endoscopy
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLL recall (Z-1427-2026) | Stryker Corporation | 2026-02-17 |