Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1
FDA 510(k) K132340 · Erbe USA, Inc.
510(k) numberK132340
Submission
- Device name
- Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1
- Applicant
- Erbe USA, Inc.
Marietta, GA, US - Received
- July 26, 2013
- Decision date
- December 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FEQ – Pump, Air, Non-Manual, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FEQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220395 | EndoGator Endoscopy Irrigation TubingFEQ · Special | STERIS Corporation | 03/11/2022SE |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMFEQ · Special | United States Endoscopy Group, Inc. | 08/01/2019SE |
| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmFEQ · Special | United States Endoscopy Group, Inc. | 09/21/2018SE |
| K173650 | AquaShield System CO2- FujifilmFEQ · Special | United States Endoscopy Group, Inc. | 01/05/2018SE |
| K163424 | AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 -…FEQ · Special | United State Endoscopy Group, Inc. | 01/04/2017SE |
| K162152 | Erbes CO2 Tubing/Cap SetsFEQ · Special | Erbe USA, Inc. | 08/31/2016SE |
| K161482 | EndoChoice Water Bottle Cap Irrigation SystemFEQ · Special | Endochoice, Inc. | 06/27/2016SE |
| K153588 | EndoChoice Water Bottle Cap SystemFEQ · Special | Endochoice, Inc. | 02/24/2016SE |
| K153362 | AquaShield system CO2, AquaShield system-PENTAXFEQ · Special | United States Endoscopy Group, Inc. | 12/16/2015SE |
| K142155 | Endochoice Water Bottle Cap SystemFEQ · Traditional | Endochoice, Inc. | 01/20/2015SE |
More from Endochoice, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221177 | Erbe's Tubing/Cap SetsOCX · Traditional | 08/11/2022SE |
| K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorOCX · Special | 06/27/2019SE |
| K190469 | ERBEFLO 2 Disposable Tubing SystemOCX · Traditional | 05/23/2019SE |
| K182444 | ERBEFLO Olympus Scope Port ConnectorOCX · Traditional | 11/06/2018SE |
| K162152 | Erbes CO2 Tubing/Cap SetsFEQ · Special | 08/31/2016SE |
| K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeGEI · Traditional | 10/27/2015SE |
| K151041 | ERBECRYO 2 Cryosurgical Unit with accessoriesGEH · Special | 05/04/2015SE |
| K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port…OCX · Special | 12/18/2014SE |
| K133180 | Erbe Esu Model Vio DV with AccessoriesGEI · Special | 12/11/2013SE |
| K103696 | Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesFEQ · Traditional | 03/22/2011SE |
Questions and answers
When was Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1 cleared by the FDA?
Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1 (K132340) received a 510(k) decision of Substantially Equivalent on December 17, 2013, 144 days after the submission was received.
What is the product code of K132340?
The FDA product code is FEQ – Pump, Air, Non-Manual, For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.