510(k) K000180
- Device
- TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
- Applicant
- RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- 510(k) number
- K000180
- Product code
- HIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-03-02
- Date received
- 2000-01-20
- 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
- ROBERT L CASARSA
- Address
- 353 Corporate Woods Pkwy. Vernon Hills IL US 60061 60061
FDA Registration Numbers#
- 3029968414
- 3038187466
- 3013557562
- 3015183635
- 3016678045
- 9614434
- 3010400367
- 3001003398
- 3021226419
- 2020550
- 3021875817
- 3001556604
- 9680340
- 9610612
- 3020746799
- 3010437008
- 3008843439
- 3026197439
- 1643817
- 1417592
- 1055236
- 1423537
- 3026753388
- 2135348
- 1317547
- 3017119401
- 8043980
- 3004605321
- 3014247825
- 2085602
- 1064584
- 3005213560
- 1531174
- 1060680
- 3008044552
- 3015241782
- 3009212837
- 3019269298
- 3008254127
- 1450997
- 1225984
- 2183744
- 2183446
- 3009495876
- 1221826
- 3033043422
- 3011137372
- 3005075853
- 1061124
- 3016248634
- 3010806467
- 3004111573
- 1836161
- 3010220595
- 3002808148
- 3015540957
- 2648666
- 3030447506
- 1526711
- 3011063460
- 3018126215
- 3010280860
- 1054241
- 3017590240
- 2249651
- 3011277660
- 2648727
- 8010273
- 9611102
- 3008573567
- 3012470322
- 3010885402
- 3005555621
- 2916714
- 2650143
- 3008837339
- 3012883081
- 3036773433
- 3014342096
- 9611665
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 |
Legacy Summary#
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FDA Review#
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