510(k) K260209
- Device
- ENDOFLATOR+; Smart Smoke Evacuation
- Applicant
- Karl Storz SE & CO. KG
- 510(k) number
- K260209
- Product code
- HIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-19
- Date received
- 2026-01-23
- 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
- Emily Rhiel
- Address
- Dr. Karl-Storz-Straße 34 Tuttlingen DE 78532 78532
FDA Registration Numbers#
- 2135348
- 1017294
- 3013557562
- 3024021261
- 3042953929
- 3007305485
- 1061124
- 1060680
- 3001556604
- 3021226419
- 3029968414
- 3012494290
- 3011277660
- 9615782
- 2936485
- 3011063460
- 9610617
- 3001003398
- 2020550
- 1319639
- 8022210
- 1317547
- 1527736
- 1220246
- 9611102
- 9616088
- 3008191256
- 1220477
- 3010383847
- 8030607
- 3010437008
- 8043980
- 9680340
- 3022626486
- 1225798
- 2648666
- 3017262662
- 1221826
- 8010273
- 3010806467
- 1450997
- 3038187466
- 3017590240
- 3010202439
- 3020704423
- 3011137372
- 1225984
- 3017119401
- 9611665
- 1043214
- 1423537
- 3010280860
- 2085602
- 3012470322
- 3005213560
- 3006897899
- 3002907620
- 2183744
- 3012883081
- 8010047
- 3003755939
- 1055236
- 3017565103
- 3008843439
- 3014279513
- 3014342096
- 2916714
- 3030447506
- 3014579161
- 3010400367
- 3003898360
- 3003627840
- 2648727
- 3015183635
- 3015612252
- 3030926959
- 1054241
- 1450662
- 1643817
- 1320894
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 |
| 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 |