MOLLI 2 System— 510(k) K253888
Substantially EquivalentStryker Endoscopy
FDA 510(k) clearance K253888 for MOLLI 2 System, Substantially Equivalent on 2025-12-31. Applicant: Stryker Endoscopy. Device class: 2.
Clearance details
- Applicant
- Stryker Endoscopy
- Product code
- Code NEU
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Recent devices under product code NEU
view all- K253761 — HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
- K252892 — SCOUT MD Surgical Guidance System
- K251989 — VizMark Preloaded Tissue Marker Device (VM-0001)
- K251748 — MammoSTAR Biopsy Site Identifier
- K243642 — UltraCor Twirl Breast Tissue Marker
More clearances from Stryker Endoscopy
view all- K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down
- DEN250040 — SportSuite Vision Software
- K253602 — Precision S 4K Sinuscope
- K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
- K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
Adverse events under product code NEU
product code NEU- Injury
- 824
- Total
- 824
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K253888
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K253888.
Data sourced from openFDA. This site is unofficial and independent of the FDA.