SimpleSnip
The FDA filing identifies SimpleSnip Endoscopic Suture Cutter models SC500160 and SC500230. It describes a sterile, single-patient-use cutter for sutures during flexible endoscopic…
The FDA filing identifies SimpleSnip Endoscopic Suture Cutter models SC500160 and SC500230. It describes a sterile, single-patient-use cutter for sutures during flexible endoscopic procedures.
The filing lists 160 cm and 230 cm working lengths for gastroscopes and colonoscopes, respectively. The device passes through a flexible endoscope working channel of at least 2.8 mm.
Listed Item
Endoscopic Suture Cutter
Cutting Action
After insertion, its blade advances from the catheter to capture a suture; pulling the blade back toward the catheter cuts the suture. The blade is rotatable for capture and cutting.
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology 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 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
Record
| Listed by | Envision Endoscopy Inc., United States |
|---|---|
| FDA product code | OCZ |
| Device type | Endoscopic Grasping/Cutting Instrument, Non-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K242923 |
| Record published | 2026-07-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SC500160 | In distribution | |
| SC500230 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoscopic Grasping/Cutting Instrument, Non-Powered | Stryker GmbH | 176 |
| Single Use Grasping Forceps | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 53 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | Karl Storz GmbH & Co. KG | 42 |
| Hobbs Medical Polypectomy Snare | Hobbs Medical, Inc. | 27 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | Richard Wolf Gmbh | 24 |
| Hysafe | Richard Wolf Gmbh | 22 |
| Grasping Forceps | Olympus Medical Systems Corp. | 17 |
| EndoTBasket | Endo-Therapeutics, Inc. | 13 |
| Halyard | Avanos Medical, Inc. | 11 |
| Hobbs Helical Retrieval Basket | Hobbs Medical, Inc. | 8 |
| Grasping Forceps | Micro-Tech (Nanjing) Co., Ltd. | 6 |
| Foreign Body Grasping Forceps | Avanos Medical, Inc. | 6 |
Showing 12 of 31. All products under Endoscopic Grasping/Cutting Instrument, Non-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242923 | 2024-12-20 |
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.