510(k) K772297
- Device
- INSUFFLATOR, MODEL G100 & 200
- Applicant
- KLI
- 510(k) number
- K772297
- Product code
- HIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-01-05
- Date received
- 1977-12-13
- Regulation
- 884.1730
- Classification name
- Insufflator, Laparoscopic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004784537
- 3013557562
- 3021875817
- 3012322232
- 3012883081
- 1319639
- 1220477
- 3029968414
- 8043980
- 1054241
- 3010331645
- 3021226419
- 3008254127
- 1317547
- 3015540957
- 8010047
- 1225984
- 3019269298
- 3009988302
- 1836161
- 1221051
- 3008573567
- 3003604053
- 3024021261
- 9610612
- 3027242374
- 3008843439
- 9616088
- 1417592
- 3017119401
- 2320762
- 3017262662
- 8030607
- 9615782
- 3009212837
- 1531174
- 3015612252
- 3033043422
- 3038187466
- 3015497424
- 9680340
- 3016248634
- 3011063460
- 9614434
- 3014342096
- 2183446
- 3010806467
- 3010383847
- 2650143
- 3010120217
- 3012494290
- 3018126215
- 3010202439
- 2916714
- 1043214
- 2085602
- 3026197439
- 8022210
- 1064584
- 3006897899
- 9611665
- 3001556604
- 1017294
- 9610617
- 3036773433
- 1527736
- 3014247825
- 2648727
- 3011277660
- 3020704423
- 3008191256
- 3016832577
- 1423537
- 3002808148
- 3016727307
- 1225798
- 1450662
- 1221826
- 3005075853
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
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