Chrysalis Intelligence · Product Codes · QAU

QAU · Hemostatic Device For Endoscopic Gastrointestinal Use

General, Plastic Surgery · 11 clearances · 6 unique sponsors

Device class
Class II
Regulation 878.4456
Total clearances
11
2020-06-10 → 2026-08-03
Last 12 months
3
Unique sponsors
6
Definition

What is Hemostatic Device For Endoscopic Gastrointestinal Use

Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.
Medical specialty
General, Plastic Surgery
Review panel
SU
Regulation number
878.4456
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
3-D Matrix, Inc. 3 1 2026-08-03
3-D Matrix Europe SAS 2 1 2026-01-07
Nextbiomedical Co., Ltd. 2 0 2024-11-27
Wilson-Cook Medical, Inc. 2 1 2026-06-02
Hemostasis, LLC 1 0 2024-07-26
Endoclot Plus Co., Ltd. 1 0 2021-01-29
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
43255 CPT — High CPT for upper endoscopic gastrointestinal hemostasis via endoscopic application
45382 CPT — High CPT for lower endoscopic gastrointestinal hemostasis via endoscopic application
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-03 K261503 3-D Matrix, Inc. PuraStat GI
2026-06-02 K253302 Wilson-Cook Medical, Inc. Hemospray Endoscopic Hemostat (HEMO-[X])
2026-01-07 K253924 3-D Matrix Europe SAS PuraStat
2024-11-27 K240994 Nextbiomedical Co., Ltd. Nexpowder
2024-10-22 K242250 3-D Matrix Europe SAS PuraStat
2024-07-26 K234131 Hemostasis, LLC Resolv Endoscopic Hemostat System
2023-02-28 K222481 3-D Matrix, Inc. PuraStat
2022-09-16 K202929 Nextbiomedical Co., Ltd. Nexpowder
2021-06-25 K210098 3-D Matrix, Inc. PuraStat-GI
2021-01-29 K190677 Endoclot Plus Co., Ltd. EndoClot
2020-06-10 K200972 Wilson-Cook Medical, Inc. Hemospray Endoscopic Hemostat