510(k) K902611
- Device
- I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR
- Applicant
- I.C. MEDICAL, INC.
- 510(k) number
- K902611
- Product code
- FYD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-17
- Date received
- 1990-06-13
- Regulation
- 878.5070
- Classification name
- Apparatus, Exhaust, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- A WILLARD
- Address
- 2340 W. Shangri La Suite 202 Phoenix AZ US 85029 85029
FDA Registration Numbers#
- 3036756245
- 1450997
- 3015967359
- 3010601992
- 1222993
- 3002707546
- 2650143
- 1450908
- 3016678045
- 3005142514
- 3013247477
- 3009882464
- 3013188547
- 1058584
- 1836161
- 3008493151
- 3003542872
- 3007728276
- 1043214
- 2320762
- 1035236
- 1718873
- 3005646850
- 1320894
- 3008805497
- 3007289408
- 1317202
- 1717344
- 3008412416
- 3030447506
- 9610773
- 3036773433
- 3010805941
- 3012821221
- 9680602
- 3007137643
- 1825014
- 3007305485
- 1417592
- 9710582
- 2028523
- 3004491689
- 3011763071
- 1043572
- 3033509898
- 3026612481
- 1527736
- 3010400367
- 3008132398
- 3025603301
- 3009380063
- 8030607
- 3020142587
- 3007997036
- 3011545081
- 2032112
- 2031894
- 3018094310
- 3003595343
- 3008786200
- 3012497308
- 3019569846
- 3016761372
- 3012494290
- 1721194
- 3027242374
- 9681191
- 3013557562
- 1061124
- 3010230734
- 1526534
- 3043226252
- 1017294
- 3005075853
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FYD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240127 | PlumeSafe X5 Smoke Management System | Conmed Corporation | 2024-08-05 |
| K233789 | 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation | 2024-04-10 |
| K213068 | Medline Smoke Evacuation Shroud | Medline Industries, Inc. | 2022-01-03 |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | Northgate Technologies, Inc. | 2021-03-25 |
| K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor | Megadyne Medical Products, Inc. | 2020-06-26 |
| K192035 | EvaQMax Smoke Evacuation System | Bio Protech, Inc. | 2019-08-29 |
| K191328 | Megadyne Foot Switch | Megadyne Medical Products, Inc. | 2019-07-26 |
| K182224 | SafeAir Smoke Evacuator compact | Lina Medical Aps | 2019-02-07 |
| K173108 | Smoklean | Sejong Medical Co., Ltd. | 2018-05-18 |
| K163659 | Crystal Vision | I.C Medical, Inc. | 2017-10-30 |
| K142335 | RapidVac Smoke Evacuator System | Covidien | 2015-01-14 |
| K131402 | VISICLEAR SMOKE EVACUATION SYSTEM | Buffalo Filter Co., Inc. | 2014-03-03 |
| K091139 | CONMED AER DEFENSE SMOKE EVACUATOR | Conmed Corporation | 2009-05-05 |
| K053464 | SERVICE MANAGER SM40SE | Conmed Integrated Systems, Canada, Ulc | 2006-06-06 |
| K052797 | LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM | Medtek Devices, Inc. | 2006-02-13 |
Legacy Summary#
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FDA Review#
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