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
Wilson-Cook Medical, Inc. 2 1 2026-06-02
3-D Matrix Europe SAS 2 1 2026-01-07
Nextbiomedical Co., Ltd. 2 0 2024-11-27
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