ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
FDA 510(k) clearance K103696 · decided 2011-03-22
Clearance details
- K-number
- K103696
- Device name
- ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
- Applicant
- Erbe USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-17
- Decision date
- 2011-03-22
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- FEQ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| EndoGator Endoscopy Irrigation Tubing (K220395) | STERIS Corporation | 2022-03-11 |
| AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM (K191559) | United States Endoscopy Group, Inc. | 2019-08-01 |
| AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm (K182258) | United States Endoscopy Group, Inc. | 2018-09-21 |
| AquaShield System CO2- Fujifilm (K173650) | United States Endoscopy Group, Inc. | 2018-01-05 |
| AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON (K163424) | United State Endoscopy Group, Inc. | 2017-01-04 |
| Erbe’s CO2 Tubing/Cap Sets (K162152) | Erbe USA, Inc. | 2016-08-31 |
| EndoChoice Water Bottle Cap Irrigation System (K161482) | Endochoice, Inc. | 2016-06-27 |
| EndoChoice Water Bottle Cap System (K153588) | Endochoice, Inc. | 2016-02-24 |
| AquaShield system CO2, AquaShield system-PENTAX (K153362) | United States Endoscopy Group, Inc. | 2015-12-16 |
| ENDOCHOICE WATER BOTTLE CAP SYSTEM (K142155) | Endochoice, Inc. | 2015-01-20 |
| ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM (K133747) | Endochoice, Inc. | 2014-01-08 |
| ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 (K132340) | Erbe USA, Inc. | 2013-12-17 |
Recalls involving this device
No recalls on record reference this clearance.