HIFLO FILTERED INSUFFLATION TUBING
FDA 510(k) clearance K930508 · decided 1993-06-25
Clearance details
- K-number
- K930508
- Device name
- HIFLO FILTERED INSUFFLATION TUBING
- Applicant
- W. J. Medical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-02-01
- Decision date
- 1993-06-25
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- FCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Newbury Park, CA, US
- Third-party review
- No
- Expedited review
- No
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| EVA5 Insufflator (K230474) | Palliare , Ltd. | 2023-03-24 |
| END 200 Endoscopic Tubeset (K202922) | Palliare , Ltd. | 2021-07-08 |
| CO2mbiLED (K201096) | Karl Storz Endoscopy America, Inc. | 2020-06-23 |
| BAROnova Insufflation System, BAROnova Accessory Kit (K190985) | Baronova, Inc. | 2019-05-14 |
| FUJIFILM Endoscopic CO2 Regulator GW-100 (K180711) | Fujifilm Corporation | 2018-05-25 |
| Nexcore GI Insufflator (K162332) | Nexcore Technology, LLC | 2016-09-29 |
| FUJIFILM ENDOSCOPIC CO2 REGULATOR (K133976) | Fujifilm Medical System U.S.A., Inc. | 2014-09-09 |
| BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR (K132192) | Bracco Diagnostic, Inc. | 2014-02-14 |
| BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (K123047) | Bracco Diagnostic, Inc. | 2013-08-06 |
| ENDOGATER AVANTAGE CO2 INSUFFLATOR (K113310) | Byrne Medical, Inc. | 2012-06-20 |
Recalls involving this device
No recalls on record reference this clearance.