Knot Pusher, Spoon Forceps and Biopsy Forceps

FDA 510(k) K940049 · Baxter Healthcare Corp

Substantially Equivalent

510(k) numberK940049

Submission

Device name
Knot Pusher, Spoon Forceps and Biopsy Forceps
Applicant
Baxter Healthcare Corp
Deerfield, IL, US
Received
January 5, 1994
Decision date
May 6, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HET – Laparoscope, Gynecologic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1720
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HET

510(k)DeviceApplicantDecision
K250939SIRIUS Endoscope System (PR-SI-1230)HET · Traditional Precision Robotics (Hong Kong) Limited08/29/2025SE
K243821i-CutHET · Traditional A.M.I. Agency For Medical Innovations GmbH04/25/2025SE
K221642SIRIUS Endoscope SystemHET · Traditional Precision Robotics (Hong Kong) Limited12/12/2022SE
K210116Video Endoscopy System, 3D Video Endoscopy SystemHET · Traditional Surgnova Healthcare Technologies (Zhejiang) Co.…10/13/2021SE
K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5HET · Traditional Olympus Medical Systems Corp.09/17/2021SE
K210104SurroundScope SystemHET · Traditional 270surgical , Ltd.07/08/2021SE
K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional Schoelly Fiberoptic GmbH03/12/2021SE
K2002164K UHD Camera SystemHET · Traditional Scivita Medical Technology Co., Ltd.08/21/2020SE
K200638LAP-iX Suction IrrigationHET · Special Sejong Medical Co., Ltd.04/03/2020SE
K190190WV1 EndoscopeHET · Traditional 270surgical , Ltd.11/01/2019SE

More from 270surgical , Ltd.

510(k)DeviceDecision
K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional 12/16/2025SE
K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional 07/28/2025SE
K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional 07/28/2025SE
K243529Solution Administration SetsFPA · Traditional 03/14/2025SE
K242339Intravascular Extension Sets and AccessoriesFPA · Traditional 02/28/2025SE
K242390Novum IQ Syringe Pump (40800BAXUS)FRN · Special 09/05/2024SE
K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISMQV · Traditional 08/02/2024SE
K230665Dose IQ Safety SoftwarePHC · Traditional 03/29/2024SE
K211122Novum IQ Large Volume PumpFRN · Traditional 03/29/2024SE
K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional 03/12/2024SE

Questions and answers

When was Knot Pusher, Spoon Forceps and Biopsy Forceps cleared by the FDA?

Knot Pusher, Spoon Forceps and Biopsy Forceps (K940049) received a 510(k) decision of Substantially Equivalent on May 6, 1994, 121 days after the submission was received.

What is the product code of K940049?

The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.