Nebulae I
Laparoscopic Insufflator 50LPM
10manufacturers in China registered for this device type
1catalogue number
16510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Unimicro Medical Systems (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Tianjin Uwell Medical Device Manufacturing Co Ltd | Tianjin | Tianjin | Manufacturer | 3 |
Record
| Listed by | Northgate Technologies Inc., United States |
|---|---|
| FDA product code | HIF |
| Device type | Insufflator, Laparoscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1730 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-10-13 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7-650-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Comeg Medical | Sopro | 20 |
| Insufflator, Laparoscopic | Richard Wolf Gmbh | 19 |
| Airseal | ConMed Corporation | 10 |
| Insufflator, Laparoscopic | Smith & Nephew, Inc. | 10 |
| Gimmi | Gimmi Gmbh | 8 |
| Insuflow Port | Lexion Medical, LLC. | 8 |
| Aesculap | Aesculap AG | 7 |
| Insufflator, Laparoscopic | Stryker GmbH | 6 |
| EVA15 | Palliare | 6 |
| Conmed | ConMed Corporation | 6 |
| Pneumosure | Stryker GmbH | 6 |
| Diversatek Healthcare | Diversatek Healthcare Inc | 6 |
Showing 12 of 114. All products under Insufflator, Laparoscopic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120151 | 2012-08-17 |
| K041560 | 2004-09-28 |
| K033614 | 2004-07-29 |
| K022052 | 2003-01-24 |
| K010053 | 2001-10-23 |
| K992381 | 1999-09-17 |
| K983326 | 1999-02-05 |
| K973447 | 1998-09-30 |
| K972675 | 1998-09-30 |
| K935862 | 1994-08-19 |
| K915051 | 1992-06-04 |
| K914403 | 1991-11-27 |
| K914401 | 1991-11-27 |
| K914402 | 1991-11-27 |
| K911179 | 1991-11-13 |
| K905481 | 1991-03-29 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-01-15 | Class II | Nonconforming Material/Component | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. | 25 units | 2022-10-31 |
| 2016-11-21 | Class II | Software design | Device could cause a patient overpressure situation without any visual or auditory indication or warning | 49 devices | 2017-11-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.