Chrysalis Intelligence · Product Codes · FBK

FBK · Endoscopic Injection Needle, Gastroenterology-Urology

Gastroenterology, Urology · 21 clearances · 20 unique sponsors

Device class
Class II
Regulation 876.1500
Total clearances
21
2020-02-27 → 2026-05-29
Last 12 months
4
Unique sponsors
20
Definition

What is Endoscopic Injection Needle, Gastroenterology-Urology

inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.1500
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Olympus Medical Systems Corporation 2 1 2025-10-16
G-Flex Europe Sprl 1 0 2023-04-03
Yangzhou Fartley Medical Instrument Technology Co., Ltd. 1 0 2022-08-19
Beijing Zksk Technology Co., Ltd. 1 0 2022-06-02
Changzhou New Med Micro-Medtech Co., Ltd. 1 1 2025-12-02
Ningbo Xinwell Medical Technology Co., Ltd. 1 0 2024-04-12
Mirco-Tech (Nanjing) Co., Ltd. 1 1 2026-05-29
Lina Medical Aps 1 0 2022-09-02
Laborie Medical Technologies, Corp. 1 0 2024-08-27
Incore Co., Ltd. 1 0 2022-12-21
Zhejiang Soudon Medical Technology Co., Ltd. 1 0 2023-11-09
Hangzhou AGS MedTech Co., Ltd. 1 0 2020-02-27
Alton (Shanghai) Medical Instruments Co., Ltd. 1 0 2023-09-27
Veol Medical Technologies Pvt , Ltd. 1 0 2025-02-27
Zhejiang Chuangxiang Medical Technology Co., Ltd. 1 0 2022-02-23
Carbon Medical Technologies, Inc. 1 1 2026-03-31
Anrei Medical (Hangzhou) Co., Ltd. 1 0 2021-05-28
Promisemed Hangzhou Meditech Co., Ltd. 1 0 2024-10-04
Jiangsu Vedkang Medical Science and Technology Co., Ltd. 1 0 2022-07-29
Steris 1 0 2024-03-08
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
43238 CPT Medium CPT code for upper endoscopy with injection of medication(s)
A4212 HCPCS Non-coring needle or stylet with or without catheter ✓ CMS-verified description Medium HCPCS code for sterile needle, 1 cc tuberculin syringe for burette
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-29 K260262 Mirco-Tech (Nanjing) Co., Ltd. Injection Needle
2026-03-31 K253598 Carbon Medical Technologies, Inc. InjecSURE Injection System
2025-12-02 K252021 Changzhou New Med Micro-Medtech Co., Ltd. Disposable Endoscopic Injection Needles
2025-10-16 K252247 Olympus Medical Systems Corporation Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)
2025-02-27 K241595 Veol Medical Technologies Pvt , Ltd. EzVu Visual Vasopressor injector (EV-19)
2024-10-04 K240675 Promisemed Hangzhou Meditech Co., Ltd. Endoscopic Injection Needles
2024-08-27 K241523 Laborie Medical Technologies, Corp. injeTAK Adjustable Tip Needle (DIS199; DIS201)
2024-04-12 K232200 Ningbo Xinwell Medical Technology Co., Ltd. Disposable Injection Needles
2024-03-08 K232826 Steris Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)
2023-11-09 K232442 Zhejiang Soudon Medical Technology Co., Ltd. Disposable Endoscope Injection Needles
2023-09-27 K230925 Alton (Shanghai) Medical Instruments Co., Ltd. Disposable Injection Needle AF series
2023-04-03 K222006 G-Flex Europe Sprl Sclerotherapy & Endoscopic Needles
2022-12-21 K221054 Incore Co., Ltd. CORE-INJECTOR
2022-09-02 K221085 Lina Medical Aps LiNA OperaScope Needle
2022-08-19 K220292 Yangzhou Fartley Medical Instrument Technology Co., Ltd. Disposable Endoscope Injection Needle
2022-07-29 K213914 Jiangsu Vedkang Medical Science and Technology Co., Ltd. Injection Needle
2022-06-02 K213239 Beijing Zksk Technology Co., Ltd. Endoscopic Injection Needle
2022-02-23 K212668 Zhejiang Chuangxiang Medical Technology Co., Ltd. Sclerotherapy Needle
2021-05-28 K210917 Anrei Medical (Hangzhou) Co., Ltd. Single Use Injection Needle
2020-04-28 K192498 Olympus Medical Systems Corp. Single Use Injector
2020-02-27 K190032 Hangzhou AGS MedTech Co., Ltd. Disposable Sclerotherapy Needle