Hi-Flo Therme Pneu 45, Wisap #7083, 7083V

FDA 510(k) K031014 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

Substantially Equivalent

510(k) numberK031014

Submission

Device name
Hi-Flo Therme Pneu 45, Wisap #7083, 7083V
Applicant
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Sauerlach, DE
Received
March 31, 2003
Decision date
June 27, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HIF – Insufflator, Laparoscopic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1730
Specialty
Obstetrics/Gynecology

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K260209ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional Karl Storz SE & CO. KG08/19/2026SE
K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)HIF · Traditional Weyo Surgical Technology , Ltd.06/25/2026SE
K252318Insufflator (OPTO-IFL1000)HIF · Traditional Guangdong Optomedic Technologies, Inc.04/16/2026SE
K250388Endoflator +HIF · Traditional Karl Storz SE & CO. KG09/22/2025SE
K242772AirSurgN Insufflator (10030/AirSurgN)HIF · Traditional SmartsurgN, Inc.04/11/2025SE
K243527High Flow Insufflation Unit (UHI-4)HIF · Traditional Olympus Medical Systems Corporation01/13/2025SE
K242536TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional Tautona Group10/15/2024SE
K232902EVA15 insufflatorHIF · Traditional Palliare , Ltd.05/02/2024SE
K232464VereSee Optical Veres Needle SystemHIF · Traditional Freyja Healthcare, LLC05/02/2024SE
K233020TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional Tautona Group Research & Development, Co., LLC01/12/2024SE

More from Tautona Group Research & Development, Co., LLC

510(k)DeviceDecision
K011510Multi Hi-Flo Pneu, Wisap #7080HIF · Traditional 04/02/2002SE
K992513Therme-Pneu Computer, Wisap #7070C, #7070CF, #7070CM, #7070CMFHET · Traditional 03/17/2000SE
K992481CO2-OP-PNEU Computer, Wisap #7050C, #7050CF, #7050CMFHET · Traditional 03/17/2000SE
K990662Disposable Heating Tubing Set #7642HSESHIF · Traditional 09/24/1999SE
K982515Power-Drive, Wisap Model #7688PD/7688PD1HET · Traditional 01/19/1999SE
K982518Aqua Purator-Biotherm, Wisap Model # 1608HET · Traditional 01/14/1999SE
K960640S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification)HET · Traditional 02/14/1997SE
K952508Flow-Therme, Wisap #7642HET · Traditional 08/25/1995SE

Questions and answers

When was Hi-Flo Therme Pneu 45, Wisap #7083, 7083V cleared by the FDA?

Hi-Flo Therme Pneu 45, Wisap #7083, 7083V (K031014) received a 510(k) decision of Substantially Equivalent on June 27, 2003, 88 days after the submission was received.

What is the product code of K031014?

The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.