IV 1000 Insufflator Rapid Flow

FDA 510(k) K910983 · M.D. Engineering, Inc.

Substantially Equivalent

510(k) numberK910983

Submission

Device name
IV 1000 Insufflator Rapid Flow
Applicant
M.D. Engineering, Inc.
Hayward, CA, US
Received
March 7, 1991
Decision date
December 9, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code HIF

510(k)DeviceApplicantDecision
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
K912882Innervision Laparoscope and AccessoriesHET · Traditional 01/24/1992SE
K910982Innervision Irrigation PumpHEI · Traditional 08/26/1991SE
K883384TS1000 Suction TipBSY · Traditional 11/02/1988SE

Questions and answers

When was IV 1000 Insufflator Rapid Flow cleared by the FDA?

IV 1000 Insufflator Rapid Flow (K910983) received a 510(k) decision of Substantially Equivalent on December 9, 1991, 277 days after the submission was received.

What is the product code of K910983?

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