HIF · Insufflator, Laparoscopic · Chrysalis Intelligence

Device class

Class II

Regulation 884.1730

Total clearances

2020-01-30 → 2026-06-25

Last 12 months

Unique sponsors

Classification details

Medical specialty

Obstetrics/Gynecology

Review panel

Regulation number

884.1730

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Palliare , Ltd.	4	0	2024-05-02
Guangdong Optomedic Technologies, Inc.	2	1	2026-04-16
Conmed Corporation	2	0	2023-09-20
Premium Medical Technology, LLC	1	0	2023-08-29
Weyo Surgical Technology , Ltd.	1	1	2026-06-25
Hangzhou Kangji Medical Instrument Co., Ltd.	1	0	2023-12-14
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.	1	0	2023-03-28
Guangzhou T.K Medical Instrument Co., Ltd.	1	0	2020-01-30
Karl Storz SE & CO. KG	1	1	2025-09-22
Freyja Healthcare, LLC	1	0	2024-05-02
Tautona Group	1	0	2024-10-15
Scivita Medical Technology Co., Ltd.	1	0	2023-05-16
SmartsurgN, Inc.	1	0	2025-04-11
W.O.M. World of Medicine GmbH	1	0	2020-07-29
Core Access Surgical Technologies, Inc.	1	0	2022-02-23
Olympus Medical Systems Corporation	1	0	2025-01-13
Tautona Group Research & Development, Co., LLC	1	0	2024-01-12

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
49320	CPT	—	Medium	Laparoscopic gynecologic procedure; insufflator provides CO2 insufflation

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-25	K252584	Weyo Surgical Technology , Ltd.	Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)
2026-04-16	K252318	Guangdong Optomedic Technologies, Inc.	Insufflator (OPTO-IFL1000)
2025-09-22	K250388	Karl Storz SE & CO. KG	ENDOFLATOR +
2025-04-11	K242772	SmartsurgN, Inc.	AirSurgN Insufflator (10030/AirSurgN)
2025-01-13	K243527	Olympus Medical Systems Corporation	High Flow Insufflation Unit (UHI-4)
2024-10-15	K242536	Tautona Group	TauTona Pneumoperitoneum Assist Device (TPAD)
2024-05-02	K232902	Palliare , Ltd.	EVA15 insufflator
2024-05-02	K232464	Freyja Healthcare, LLC	VereSee Optical Veres Needle System
2024-01-12	K233020	Tautona Group Research & Development, Co., LLC	TauTona Pneumoperitoneum Assist Device (TPAD)
2023-12-14	K232401	Hangzhou Kangji Medical Instrument Co., Ltd.	Disposable Veress Needles
2023-09-20	K231342	Guangdong Optomedic Technologies, Inc.	Insufflator (OPTO-IFL1000)
2023-09-20	K230239	Conmed Corporation	AirSeal iFS System; AirSeal dV Solution
2023-08-29	K231407	Premium Medical Technology, LLC	StarFin
2023-05-16	K222812	Scivita Medical Technology Co., Ltd.	Insufflator
2023-03-28	K221995	Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.	Gas Insufflator
2023-01-27	K222901	Palliare , Ltd.	EVA15 insufflator
2022-02-23	K212786	Core Access Surgical Technologies, Inc.	LevaLap Laparoscopic Access Device
2021-08-19	K211104	Conmed Corporation	AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
2020-10-21	K202799	Palliare , Ltd.	EVA15
2020-07-29	K201361	W.O.M. World of Medicine GmbH	PNEUMOCLEAR
2020-07-23	K193520	Palliare , Ltd.	EVA 15 Insufflator
2020-01-30	K193339	Guangzhou T.K Medical Instrument Co., Ltd.	GTK Veress Needles