FDA.reportPublic FDA data

InflaCure

Primary DI
16972304751555
Brand
InflaCure
Company
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Model
GI-S001
Device description
Insufflation Tubing Set
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIFInsufflator, Laparoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221995000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221995000Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.2023-03-28HIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972304751555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697230475155516972304751555

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic insufflatorA mains electricity (AC-powered) device designed to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space (pneumoperitoneum) in which to perform an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. Other surgical instruments may be introduced into the peritoneal cavity through other laparoscopic ports. This device may also be referred to as a gas distention system.

Regulatory Flags#

DUNS number
550274579
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972304750407DeepEyeEVS1002026-05-22
06972304750414DeepEyeEVS2002026-05-22
06972304750834DophiNPG30002026-05-22
06972304751404InflaCureGVS1002026-05-22
16972304750381DeepEyeLPS210002026-05-22
16972304750398DeepEyeLPS210302026-05-22
16972304750428DeepEyeLPS310002026-05-22
16972304750435DeepEyeLPS310302026-05-22
16972304750770DophiNSP132026-05-22
16972304750787DophiNSP182026-05-22
16972304750794DophiNSP252026-05-22
16972304750800DophiNTP132026-05-22
16972304750817DophiNTP182026-05-22
16972304750824DophiNTP252026-05-22
16972304750848DophiNFS062026-05-22
06972304750667VaricureSC300ES2022-10-27
06972304750681VaricureSC200ES2022-10-27
06972304750698VaricureSC100ES2022-10-27
06972304750704VaricureES1002022-10-27
06972304750711VaricureES2002022-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972304751404InflaCureSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HIF2026-05-22
10851885004587AIRSEALConmed CorporationHIF2026-03-21
00860012249954VereSeeFreyja Healthcare, LLCHIF2025-06-18
00860012249916VereSeeFreyja Healthcare, LLCHIF2025-06-16
G465100300AirSurgN InsufflatorSmartsurgn Inc.HIF2025-04-22
04953170467226INSUFFLATION TUBEOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-26
04953170467233SUCTION TUBEOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-26
05391536920142EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920159EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920913EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920944EVA15PALLIARE LIMITEDHIF2024-07-16
06937845500607GTKGuangzhou T.K Medical Instrument Co.,Ltd.HIF2024-05-23
06937845500614GTKGuangzhou T.K Medical Instrument Co.,Ltd.HIF2024-05-23
20845854045630AIRSEALConmed CorporationHIF2024-03-27
06973031299573Insufflation tubeGuangdong Optomedic Technologies, Inc.HIF2024-03-26
06973031299870Insufflation tubeGuangdong Optomedic Technologies, Inc.HIF2024-03-26
06973031299887InsufflatorGuangdong Optomedic Technologies, Inc.HIF2024-03-26
10886874120696NoneINTUITIVE SURGICAL, INC.HIF2024-03-25
06971381251357InsufflatorSCIVITA MEDICAL TECHNOLOGY CO., LTD.HIF2024-02-28
06971381251364InsufflatorSCIVITA MEDICAL TECHNOLOGY CO., LTD.HIF2024-02-28
10845854045350CONMEDConmed CorporationHIF2023-12-04
10845854045398CONMEDConmed CorporationHIF2023-12-04
00810143450545MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpHIF2023-07-31
00810143450750MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpHIF2023-07-31
09420012433060Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
09420012433985Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
00850082007189Filter AssemblyARMM INC.HIF2023-06-08
00850082007196Insufflator Filter AssemblyARMM INC.HIF2023-06-08
00850082007837Insufflator Filter AssemblyARMM INC.HIF2023-06-08
05060660970025TEMEDTemedHIF2023-04-21