510k
Database
Specialties
Anesthesiology
522
Cardiovascular
1608
Chemistry
356
Dental
1300
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2131
General Hospital
1973
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
940
Obstetrics & Gynecology
426
Ophthalmic
271
Orthopedic
2696
Pathology
52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
402
LLZ
System, Image Processing,...
367
GEX
Powered Laser Surgical Instrument
350
FXX
Mask, Surgical
346
GEI
Electrosurgical, Cutting &...
294
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Piccolo Medical, Inc.
Medical Device Manufacturer
·
US , San Francisco , CA
Piccolo Medical, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2021
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Piccolo Medical, Inc.
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 17, 2025
PM2™ System with ECGuide™ Connector
K252792
·
LJS
Cardiovascular
·
76d
Cleared
May 29, 2025
PM2+ System and SmartPICC Stylet
K243484
·
LJS
Cardiovascular
·
202d
Cleared
Sep 08, 2024
PM2 System and ECGuide Connector
K240486
·
LJS
Cardiovascular
·
201d
Cleared
Jan 22, 2021
Piccolo Medical SmartPICC System
K200037
·
LJS
Cardiovascular
·
380d
Filters
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4
Cardiovascular
4