510(k) K955393
- Device
- NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
- Applicant
- SURGICAL INNOVATIONS PLC
- 510(k) number
- K955393
- Product code
- HIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-09
- Date received
- 1995-11-24
- Regulation
- 884.1730
- Classification name
- Insufflator, Laparoscopic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL A CLARK
- Address
- 1070 Thornwood Ln. Dacula GA US 30211 30211
FDA Registration Numbers#
- 3014279513
- 3010437008
- 9616088
- 3016248634
- 3004605321
- 1061124
- 9614434
- 3010331645
- 3015806723
- 3008843439
- 9615782
- 2183446
- 3026753388
- 3027242374
- 3030447506
- 3015974593
- 1064584
- 2020550
- 3011137372
- 2936485
- 3010707607
- 3016678045
- 3010202439
- 1220246
- 3007305485
- 8010047
- 2648727
- 3014579161
- 9610617
- 1057358
- 3008044552
- 2135348
- 3005075853
- 1220477
- 1417592
- 1221826
- 3015241782
- 3015976667
- 3017262662
- 9680340
- 1060680
- 3030926959
- 3008254127
- 1225798
- 1423662
- 3001003398
- 1225984
- 3010120217
- 3013557562
- 3012322232
- 3006897899
- 1450662
- 3010806467
- 3009212837
- 3010041511
- 3011277660
- 3008191256
- 3002907620
- 3005213560
- 3010383847
- 1450997
- 1836161
- 1055236
- 2916714
- 9611102
- 3015183635
- 3009495876
- 3017565103
- 2648666
- 3010280860
- 3002808148
- 3018126215
- 3004784537
- 3008837339
- 1527736
- 3019269298
- 3036773433
- 2085602
- 3017119401
- 8043980
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HIF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K222901 | EVA15 insufflator | Palliare , Ltd. | 2023-01-27 |
Legacy Summary#
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FDA Review#
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