510(k) K910716
- Device
- MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE
- Applicant
- RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- 510(k) number
- K910716
- Product code
- FCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-04-16
- Date received
- 1991-02-20
- Regulation
- 876.1500
- Classification name
- Insufflator, Automatic Carbon-dioxide For Endoscope
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT L CASARSA
- Address
- 7046 Lyndon Ave. Rosemont IL US 60018 60018
FDA Registration Numbers#
- 3024021261
- 2518897
- 1450997
- 9611102
- 3014749926
- 3012322232
- 3008058134
- 1651395
- 1423662
- 9614434
- 3015974593
- 3017590240
- 3042225166
- 2411512
- 3010707607
- 8010047
- 3011050570
- 3021023752
- 3010291427
- 3017565103
- 3003775006
- 9610617
- 3010202439
- 3016727307
- 2020550
- 3002808148
- 3003604053
- 3014342096
- 3013460719
- 1528319
- 3010612620
- 3021349683
- 3003174284
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FCX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240847 | MedicCO2LON (MedicCO2LON) | Ide Vision, Ltd. | 2024-10-30 |
| K230474 | EVA5 Insufflator | Palliare , Ltd. | 2023-03-24 |
| K202922 | END 200 Endoscopic Tubeset | Palliare , Ltd. | 2021-07-08 |
| K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | 2020-06-23 |
| K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. | 2019-05-14 |
| K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100 | Fujifilm Corporation | 2018-05-25 |
| K162332 | Nexcore GI Insufflator | Nexcore Technology, LLC | 2016-09-29 |
| K133976 | FUJIFILM ENDOSCOPIC CO2 REGULATOR | Fujifilm Medical System U.S.A., Inc. | 2014-09-09 |
| K132192 | BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR | Bracco Diagnostic, Inc. | 2014-02-14 |
| K123047 | BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET | Bracco Diagnostic, Inc. | 2013-08-06 |
| K113310 | ENDOGATER AVANTAGE CO2 INSUFFLATOR | Byrne Medical, Inc. | 2012-06-20 |
| K111648 | BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR | Bracco Diagnostic, Inc. | 2011-11-03 |
| K090879 | INSUFLOW CO2IONSHIELD | Lexion Medical, LLC | 2009-07-23 |
| K063786 | ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 | Olympus Medical Systems Corporation | 2007-03-05 |
| K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | E-Z-Em, Inc. | 2005-12-27 |
Legacy Summary#
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FDA Review#
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