Beijing Zksk Technology Co., Ltd.
beijing, CN
BEIJING ZKSK TECHNOLOGY CO., LTD. appears in FDA device records in beijing, CN. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Beijing Zksk Technology Co., Ltd. between 2022 and 2025. The busiest year on record is 2022, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 4 |
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242192 | Disposable Sphincterotome | KNS | Substantially Equivalent | |
| K231721 | Disposable Hot Biopsy Forceps | KGE | Substantially Equivalent | |
| K213217 | Disposable hemoclip | PKL | Substantially Equivalent | |
| K213223 | Multi-Band Ligator | FHN | Substantially Equivalent | |
| K213222 | Disposable Polypectomy Snare | FDI | Substantially Equivalent | |
| K213239 | Endoscopic Injection Needle | FBK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014620201 | 3014620201 | BEIJING ZKSK TECHNOLOGY CO., LTD. | Building 9, 6 & No.6 Yuan Hengye North 7th street, Yongle Economic Development Zone, Tongzhou District, beijing 101105 CN | 2026 | and 28 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXGApplicator, Absorbent Tipped, Sterile
- KYRBag, Ice
- FQMBandage, Elastic
- FYFCap, Surgical
- FZPClip, Implantable
- EFNCotton, Roll
- FXPCover, Shoe, Operating-Room
- KBLDepressor, Metal Tongue, Surgical
- FMADepressor, Tongue, Non-Surgical
- GCCDilator, Catheter
- FYEDress, Surgical
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- QKRFace Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- LRRFirst Aid Kit With Drug
- KGEForceps, Biopsy, Electric
- FCLForceps, Biopsy, Non-Electric
- EFLForceps, Dressing, Dental
- EMGForceps, Tooth Extractor, Surgical
- PKLHemostatic Metal Clip For The Gi Tract
- DZNInstruments, Dental Hand
- FQHLavage, Jet
- MNDLigator, Esophageal
- FHNLigator, Hemorrhoidal
- KHAMask, Scavenging
- EAXMirror, Mouth
- JDZMixer, Cement, For Clinical Use
- OEANon-Surgical Gown
- EIXProbe, Periodontic
- MSHRespirator, Surgical
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- FDISnare, Flexible
- ILHSplint, Hand, And Components
- FXOSuit, Surgical
- FQZThermometer, Clinical Color Change
- GAXTourniquet, Nonpneumatic
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain