510(k) K030469
- Device
- LAPAROSHIELD CONDITIONED INSUFFLATION SET
- Applicant
- PALL MEDICAL
- 510(k) number
- K030469
- Product code
- HIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-05-09
- Date received
- 2003-02-12
- 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
- JONATHAN S KAHAN
- Address
- 555 Thirteenth St. NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3026197439
- 1423662
- 3004784537
- 3012470322
- 3033043422
- 3015974593
- 3009988302
- 3015540957
- 1836161
- 3010400367
- 1643264
- 3010280860
- 2650143
- 1320894
- 3001556604
- 3005213560
- 3016727307
- 3010806467
- 1064584
- 8010047
- 3012883081
- 9611451
- 1220477
- 3022626486
- 1221826
- 3004111573
- 3016678045
- 3015806723
- 2028523
- 3001675293
- 3036773433
- 2020550
- 3011277660
- 3008573567
- 2183744
- 1319639
- 2648666
- 2955842
- 3007305485
- 9615782
- 9680340
- 1450662
- 3014342096
- 3017262662
- 1643817
- 3003755939
- 2085602
- 2183446
- 1225984
- 3010120217
- 3010383847
- 3003627840
- 2249651
- 9610612
- 3008837339
- 3010331645
- 3016248634
- 3010041511
- 3013557562
- 3015241782
- 8030607
- 9610617
- 3014611142
- 3021226419
- 3019269298
- 1017294
- 3014247825
- 3017565103
- 3016832577
- 3024021261
- 1531174
- 3002808148
- 3003898360
- 1317547
- 3027242374
- 3015976667
- 3029968414
- 3038187466
- 3010437008
- 2135348
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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