Chrysalis Intelligence · Product Codes · GAG

GAG · Unclassified

11 clearances · 5 unique sponsors

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Device class

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Regulation —

Total clearances

11

2022-04-08 → 2026-07-01

Last 12 months

1

Unique sponsors

5

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Covidien	5	1	2026-07-01
Ethicon Endo-Surgery, LLC	2	0	2024-07-03
Lexington Medical, Inc.	2	0	2025-07-11
Covidien (Part of Medtronic)	1	0	2024-11-01
Intuitive Surgical, Inc.	1	0	2025-03-10

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.

Code	Type	Description	Confidence	Rationale
35810	CPT	—	Medium	Surgical stapler for anastomosis/resection; varies by anatomic site and procedure
99070	CPT	—	Medium	Surgical supplies code when stapler/staples billed separately from procedure

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-01	K253527	Covidien, LLC	Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
2025-07-11	K251482	Lexington Medical, Inc.	AEON Endoscopic Powered Stapler
2025-03-10	K243596	Intuitive Surgical, Inc.	da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
2024-11-01	K240881	Covidien (Part of Medtronic)	Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)
2024-07-03	K241629	Ethicon Endo-Surgery, LLC	ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)
2024-05-07	K234039	Lexington Medical, Inc.	AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
2023-10-27	K231934	Covidien	GIA Stapler with Tri-Staple Technology
2023-08-16	K232126	Covidien	EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil
2023-08-16	K231491	Covidien	TA Stapler and Loading Unit with DST Series Technology
2023-02-22	K221629	Covidien	Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)
2022-04-08	K213633	Ethicon Endo-Surgery, LLC	ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler