510(k) K913979
- Device
- ENDO I/A Y SET
- Applicant
- SNOWDEN-PENCER
- 510(k) number
- K913979
- Product code
- HIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-11-27
- Date received
- 1991-09-06
- 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
- NORMAN M BLACK
- Address
- 2058 Kilman Dr. Tucker GA US 30084 30084
FDA Registration Numbers#
- 3015976667
- 2955842
- 3008837339
- 1450997
- 1220477
- 9614434
- 3008843439
- 3010280860
- 3010220595
- 3021226419
- 1220246
- 3015806723
- 9615782
- 3017590240
- 3026753388
- 3014342096
- 3010400367
- 3033043422
- 1423537
- 3012883081
- 3001556604
- 1043214
- 8043980
- 3010806467
- 2650143
- 3020746799
- 3001675293
- 9610612
- 3004491689
- 3007305485
- 3007791595
- 3006897899
- 3014579161
- 2249651
- 8030607
- 1221051
- 1320894
- 1643817
- 3029968414
- 3005075853
- 3008573567
- 3011137372
- 3015974593
- 3019269298
- 3016678045
- 1055236
- 1225984
- 9611665
- 2648727
- 2085602
- 1225798
- 3009212837
- 3008254127
- 2183744
- 3014279513
- 3030447506
- 3008044552
- 1643264
- 3002808148
- 3003604053
- 1060680
- 2028523
- 3002259632
- 3017119401
- 3004111573
- 3001003398
- 3008191256
- 2183446
- 3003755939
- 3010041511
- 3005213560
- 3003898360
- 9616088
- 3015183635
- 3016248634
- 3015241782
- 1054241
- 2648666
- 1526711
- 1017294
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
Legacy Summary#
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FDA Review#
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