Hand Mirror (Endoscope)

FDA 510(k) K862717 · Simpson/Basye, Inc.

Substantially Equivalent

510(k) numberK862717

Submission

Device name
Hand Mirror (Endoscope)
Applicant
Simpson/Basye, Inc.
Wilmington, DE, US
Received
July 17, 1986
Decision date
July 30, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GCO – Endoscope, Mirror
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Other 510(k)s with product code GCO

510(k)DeviceApplicantDecision
K862838Cytotech HSV Igg Enzyme ImmunoassayGCO · Traditional Cytotech, Inc.12/09/1986SE
K790340Delta-RolGCO · Traditional Johnson & Johnson Professionals, Inc.04/12/1979SE

More from Johnson & Johnson Professionals, Inc.

510(k)DeviceDecision
K926179Sedlacek HandleHGI · Traditional 03/25/1994SE
K891352Marlow Anal SpeculumKOA · Traditional 06/23/1989SE
K891351Newport Lateral Vaginal RetractorKOH · Traditional 05/11/1989SE
K891350Newport Cervical ManipulatorHDC · Traditional 03/29/1989SE
K891349Campion Cervical HookHDC · Traditional 03/29/1989SE
K891347Reid Endocervical SpreaderHDC · Traditional 03/29/1989SE
K891348Campion Laser ForcepsGEN · Traditional 03/22/1989SE
K870276Heated Instrument BathLRJ · Traditional 05/07/1987SE
K862629Surgical Laser Accessories (Sla) CaseFSM · Traditional 07/17/1986SE
K790923Mi-Mark Endocervical Sampling SetKNA · Traditional 06/22/1979SE

Questions and answers

When was Hand Mirror (Endoscope) cleared by the FDA?

Hand Mirror (Endoscope) (K862717) received a 510(k) decision of Substantially Equivalent on July 30, 1986, 13 days after the submission was received.

What is the product code of K862717?

The FDA product code is GCO – Endoscope, Mirror, a Class II (moderate risk) device regulated under 21 CFR 876.1500.