510(k) K252584
- Device
- Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)
- Applicant
- Weyo Surgical Technology , Ltd.
- 510(k) number
- K252584
- Product code
- HIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-25
- Date received
- 2025-08-15
- 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
- N
Applicant Contact#
- Contact
- Jianfeng Wang
- Address
- Rm. 313, Bldg. 3, 56 Ling Zhi Rd., Xuan Wu District Nanjing CN 210000 210000
FDA Registration Numbers#
- 3015497424
- 1225984
- 3001003398
- 3014579161
- 1220246
- 3010707607
- 3005213560
- 2648727
- 3015612252
- 1320894
- 3038187466
- 3008843439
- 3010437008
- 3008191256
- 3004784537
- 3004605321
- 2936485
- 3020704423
- 3021226419
- 9680340
- 3017262662
- 3004491689
- 3012883081
- 3001675293
- 3021875817
- 3027242374
- 3010400367
- 3003898360
- 8030607
- 1055236
- 9616088
- 1225798
- 9611102
- 3011063460
- 9610617
- 9615782
- 1064584
- 8010047
- 2183446
- 3007791595
- 1061124
- 3010120217
- 1057358
- 1043214
- 3009988302
- 3005555621
- 8043980
- 9614434
- 2916714
- 3015183635
- 8010273
- 3011137372
- 1060680
- 3020746799
- 3022626486
- 3016727307
- 2183744
- 3018126215
- 3014247825
- 2135348
- 2650143
- 1643817
- 3005075853
- 3015241782
- 3016832577
- 1836161
- 1417592
- 1423662
- 3016678045
- 9611451
- 3004111573
- 3036773433
- 9611665
- 3017565103
- 3003755939
- 3015540957
- 3017119401
- 1221051
- 1527736
- 3029968414
Source Documents#
Other 510(k) Records For Product Code HIF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260209 | ENDOFLATOR+; Smart Smoke Evacuation | Karl Storz SE & CO. KG | 2026-08-19 |
| 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 |
| K232464 | VereSee Optical Veres Needle System | Freyja Healthcare, LLC | 2024-05-02 |
| K232902 | EVA15 insufflator | Palliare , Ltd. | 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 |
| K230239 | AirSeal iFS System; AirSeal dV Solution | Conmed Corporation | 2023-09-20 |
| K231342 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2023-09-20 |
| K231407 | StarFin | Premium Medical Technology, LLC | 2023-08-29 |
| K222812 | Insufflator | Scivita Medical Technology Co., Ltd. | 2023-05-16 |
| K221995 | Gas Insufflator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2023-03-28 |