Schoelly Rigid Endoscopes

FDA 510(k) K992437 · Fiber Imaging Technologies, Inc.

Substantially Equivalent

510(k) numberK992437

Submission

Device name
Schoelly Rigid Endoscopes
Applicant
Fiber Imaging Technologies, Inc.
Newton, MA, US
Received
July 22, 1999
Decision date
September 14, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GCJ – Laparoscope, General & Plastic Surgery
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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More from TroCare, LLC

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K993300Coldlightsource PL3000FCW · Traditional 11/05/1999SE
K992527Uretero-RenoscopeFGB · Traditional 10/13/1999SE
K992040Flexiscope II Arthroscopes and AccessoriesHRX · Traditional 08/06/1999SE
K991560Naso-Laryngo-PharyngoscopeEOB · Traditional 07/13/1999SE

Questions and answers

When was Schoelly Rigid Endoscopes cleared by the FDA?

Schoelly Rigid Endoscopes (K992437) received a 510(k) decision of Substantially Equivalent on September 14, 1999, 54 days after the submission was received.

What is the product code of K992437?

The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.