510(k) K231407
- Device
- StarFin
- Applicant
- Premium Medical Technology, LLC
- 510(k) number
- K231407
- Product code
- HIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-29
- Date received
- 2023-05-15
- Regulation
- 884.1730
- Classification name
- Insufflator, Laparoscopic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kuowei Chang
- Address
- 1377 Main St. 2nd Floor Waltham MA US 02451 02451
FDA Registration Numbers#
- 3008573567
- 3024021261
- 1423537
- 2135348
- 3003898360
- 3021875817
- 3042953929
- 9680340
- 9610612
- 1423662
- 3015974593
- 3010437008
- 3036773433
- 3007305485
- 3005213560
- 3019269298
- 3016248634
- 8010047
- 3010400367
- 3010202439
- 2936485
- 3002907620
- 9616088
- 3008843439
- 3010331645
- 3004784537
- 3012883081
- 3005555621
- 1319639
- 1054241
- 3001675293
- 2955842
- 3012470322
- 8010273
- 9611102
- 9611665
- 3010120217
- 3002259632
- 1220477
- 3010220595
- 3015183635
- 3014611142
- 9614434
- 2183446
- 1221826
- 1055236
- 3014247825
- 3010806467
- 3004111573
- 3029968414
- 1527736
- 3017565103
- 8030607
- 1643817
- 9611451
- 2020550
- 3002808148
- 3018126215
- 3021226419
- 3007791595
- 1061124
- 3009212837
- 3015241782
- 1221051
- 1017294
- 3010383847
- 1220246
- 3015612252
- 3015497424
- 3016678045
- 2249651
- 1836161
- 1060680
- 2320762
- 1043214
- 3026197439
- 1320894
- 3020746799
- 2916714
- 3001556604
Source Documents#
Other 510(k) Records For Product Code HIF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252318 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2026-04-16 |
| K250388 | ENDOFLATOR + | Karl Storz SE & CO. KG | 2025-09-22 |
| K242772 | AirSurgN Insufflator (10030/AirSurgN) | SmartsurgN, Inc. | 2025-04-11 |
| K243527 | High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corporation | 2025-01-13 |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group | 2024-10-15 |
| K232902 | EVA15 insufflator | Palliare , Ltd. | 2024-05-02 |
| K232464 | VereSee Optical Veres Needle System | Freyja Healthcare, LLC | 2024-05-02 |
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC | 2024-01-12 |
| K232401 | Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. | 2023-12-14 |
| K231342 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2023-09-20 |
| K230239 | AirSeal iFS System; AirSeal dV Solution | Conmed Corporation | 2023-09-20 |
| K222812 | Insufflator | Scivita Medical Technology Co., Ltd. | 2023-05-16 |
| K221995 | Gas Insufflator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2023-03-28 |
| K222901 | EVA15 insufflator | Palliare , Ltd. | 2023-01-27 |
| K212786 | LevaLap Laparoscopic Access Device | Core Access Surgical Technologies, Inc. | 2022-02-23 |