510(k) K231579
- Device
- MOLLI 2
- Applicant
- Molli Surgical, Inc.
- 510(k) number
- K231579
- Product code
- NEU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-26
- Date received
- 2023-05-31
- Regulation
- 878.4300
- Classification name
- Marker, Radiographic, Implantable
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Joseph De Croos
- Address
- 50 Wellington St. E. Suite 400 Toronto CA M5E 1C8 M5E 1C8
FDA Registration Numbers
- 1222780
- 3011162972
- 2029275
- 3007200016
- 3006981798
- 9680340
- 1211566
- 2951215
- 3014680735
- 3021008900
- 3007055279
- 3005636544
- 1625425
- 2134494
- 3008627763
- 3018024590
- 2936485
- 3002907620
- 3018094310
- 3021179744
- 1018233
- 3008492462
- 1835568
- 3015439135
- 1928237
- 3015924373
- 3009649442
- 1064858
- 3020733550
- 1220477
- 2020394
- 1020279
- 3004111573
- 3013012623
- 1825034
- 3009039068
- 1644312
- 3007305589
- 1037905
- 3014090621
- 3011245468
- 1417485
- 3009905888
- 1222140
- 3008706707
- 3016678045
- 3015207155
- 2022435
- 9617429
- 3030733800
- 2032338
- 3013649990
- 1054811
- 3033589330
- 3008744062
- 3019807891
- 3009077524
- 3008236846
- 3013176080
- 1000393132
- 3008992312
- 3004904811
- 3035366890
- 1647149
- 3015225571
- 3006082230
- 3014967969
- 3005160949
- 3000126629
- 3009609358
- 3012644426
- 3038503932
- 3010813819
- 2183744
- 3012345110
- 3015309643
- 3006950086
- 1450662
- 3010339638
Source Documents
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| K231468 | SCOUT MD Surgical Guidance System | Merit Medical System, Inc. | 2024-02-12 |
| K230836 | SchurSign Tissue Marker | Surgmark GmbH | 2024-01-23 |