Sesis
Single-use endoscopic suction and irrigation set intended for anorectal endoscopic procedures with compatible endoscopic systems. The device facilitates controlled irrigation and suction to…
Single-use endoscopic suction and irrigation set intended for anorectal endoscopic procedures with compatible endoscopic systems. The device facilitates controlled irrigation and suction to assist visualization during procedures.
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Unimicro Medical Systems (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Heng Chuang Plastic & Metal Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Surgease Innovations Ltd, United Kingdom |
|---|---|
| FDA product code | FCZ |
| Device type | Tube, Smoke Removal, Endoscopic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-05-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature 10 to 40 °C; Storage environment humidity 20 to 95 % RH; Storage environment atmospheric pressure 700 to 1060 KiloPascal |
| Packaging | Carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SIS-CSB-101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgimedics® | Coastal Life Technologies, Inc. | 40 |
| Marina Medical | Marina Medical Instruments, Inc. | 19 |
| Gynex | Gynex Corporation | 6 |
| Tube, Smoke Removal, Endoscopic | Coastal Life Technologies, Inc. | 5 |
| Pneuview XE | Lexion Medical, LLC. | 2 |
| Tube, Smoke Removal, Endoscopic | Karl Storz GmbH & Co. KG | 2 |
| SeeClear MAX Laparoscopic Smoke Evacuation System | Coopersurgical, Inc. | 1 |
| Laparoscopic Smoke Evacuator | THE O R Company PTY Ltd | 1 |
| Laparoscopic Tubing | Megadyne Medical Products, Inc. | 1 |
| Speculum Tubing | Megadyne Medical Products, Inc. | 1 |
| Unimax | Unimax Medical Systems Inc. | 1 |
| Tubing, sterile, for UHl smoke evacuation | Promepla | 1 |
Showing 12 of 17. All products under Tube, Smoke Removal, Endoscopic
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.