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510(k) K900958

Device
GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM
Applicant
SOLOS ENDOSCOPY, INC.
510(k) number
K900958
Product code
GEJ  
Decision
Substantially Equivalent (SESE)
Decision date
1990-04-18
Date received
1990-02-27
Regulation
878.4800
Classification name
Carrier, Ligature
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEILA H HOLMES
Address
6191 Atlantic Blvd. Suite 4 Norcross GA US 30071 30071

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GEJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240185Cypris eXact Suture Placement DeviceCypris Medical2024-05-03
K900959GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATEDSolos Endoscopy, Inc.1990-04-18
K884553STAMEY NEEDLECook Ob/Gyn1988-11-14
K874342LIGATURE CARRIER/PACKER, HYDROXYLAPATITECox-Uphuff Intl.1987-11-13

Legacy Summary#

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FDA Review#

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