510k
Database
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Anesthesiology
542
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1680
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365
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1337
Ear, Nose, Throat
248
Gastroenterology & Urology
972
General & Plastic Surgery
2194
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2047
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126
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99
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8
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469
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965
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433
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275
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2923
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52
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515
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2442
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
305
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System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Surgical Principals, Inc.
Medical Device Manufacturer
·
US , Pierce , WA
Surgical Principals, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Surgical Principals, Inc.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 22, 2025
SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System
K251743
·
GCJ
General & Plastic Surgery
·
108d
Cleared
Dec 01, 2023
LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes
K230621
·
GEI
General & Plastic Surgery
·
270d
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2
General & Plastic Surgery
2