Mahe Instruments

FDA 510(k) K991426 · Mahe Intl., Inc.

Substantially Equivalent

510(k) numberK991426

Submission

Device name
Mahe Instruments
Applicant
Mahe Intl., Inc.
Nashville, TN, US
Received
April 23, 1999
Decision date
August 5, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FDC – Resectoscope, Working Element
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FDC

510(k)DeviceApplicantDecision
K021166Acmi Bipolar Rectoscope, Model Eiwe-BrFDC · Special Acmi-Circon Corporation05/09/2002SE
K992141Olympus Working Element for ProbesFDC · Traditional Olympus Winter & Ibe GmbH09/29/1999SE
K942626Continuous Flow Biopsy ProbeFDC · Traditional Gm Engineering, Inc.05/30/1995SE
K933962GM Continuous Flow Biopsy ProbeFDC · Traditional Gm Engineering, Inc.02/25/1994SE
K895643Modified Uropump* Fluid Management SystemFDC · Traditional Orthoconcept, Inc.10/17/1989SE
K894363Uropump* Fluid Management SystemFDC · Traditional Orthoconcept, Inc.08/11/1989SE
K842997Laser Rectoscope Set 784FDC · Traditional Laser Industries , Ltd.08/27/1984SE
K760184Element, WorkingFDC · Traditional V. Mueller O.V. Baxter Healthcare Corp.12/02/1976SE
K760182Sheath, ResectoscopeFDC · Traditional V. Mueller O.V. Baxter Healthcare Corp.12/02/1976SE
K760174Adapter, ResectoscopeFDC · Traditional V. Mueller O.V. Baxter Healthcare Corp.08/30/1976SE

More from V. Mueller O.V. Baxter Healthcare Corp.

510(k)DeviceDecision
K030857Mahe Pediatric Naso Pharyngoscope Its Associated and Ancillary Equipment and Endoscopic…EOB · Traditional 10/16/2003SE
K942823Mahe InstrumentsDWG · Traditional 12/05/1994SE

Questions and answers

When was Mahe Instruments cleared by the FDA?

Mahe Instruments (K991426) received a 510(k) decision of Substantially Equivalent on August 5, 1999, 104 days after the submission was received.

What is the product code of K991426?

The FDA product code is FDC – Resectoscope, Working Element, a Class II (moderate risk) device regulated under 21 CFR 876.1500.