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#
- 3001675293
- 3012322232
- 3015183635
- 3010220595
- 3016678045
- 3042953929
- 3012470322
- 3015806723
- 3021875817
- 3004111573
- 3010280860
- 9616088
- 3011137372
- 3011277660
- 3005075853
- 3010806467
- 3022626486
- 3010437008
- 2916714
- 3030926959
- 1017294
- 1043214
- 3017262662
- 3005213560
- 3026753388
- 8022210
- 1225798
- 3008595179
- 3036773433
- 3004784537
- 9611451
- 3003755939
- 3008254127
- 3008191256
- 3014579161
- 1220246
- 3010041511
- 2249651
- 9611665
- 3003604053
- 3017119401
- 1450997
- 3033043422
- 1319639
- 3001556604
- 3014247825
- 3015612252
- 1221826
- 3008837339
- 1054241
- 1531174
- 3010383847
- 3003898360
- 3020704423
- 1055236
- 1527736
- 3015540957
- 3014611142
- 3030447506
- 3015974593
- 1450662
- 3016727307
- 2183446
- 3001003398
- 3005555621
- 2020550
- 1423537
- 2650143
- 3009212837
- 1526711
- 9615782
- 3009988302
- 9614434
- 3008044552
- 3015241782
- 3008573567
- 1057358
- 3029968414
- 3027242374
- 3013557562
Source Documents#
Other 510(k) Records For Product Code HIF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) | Weyo Surgical Technology , Ltd. | 2026-06-25 |
| 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 |