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Reusable Probes

FDA 510(k)

Class II (US FDA 510(k))

510(k) K943070

by Surgin Surgical Instrumentation, Inc.

Identifiers

510(k) Number
K943070 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Reusable Probes are a type of medical device classified under product code GCJ. They are designed for use in gastroenterology and urology procedures.

These probes are supplied as reusable instruments and were cleared via the FDA 510(k) pathway under K943070 on July 22, 1994, by Surgin Surgical Instrumentation, Inc. The device is intended for use in clinical settings where endoscopic or urological probing is required.

Frequently asked questions

What are Reusable Probes used for?

Reusable Probes are designed for use in gastroenterology and urology procedures where endoscopic or urological probing is required, as indicated in the device description and intended use.

How are Reusable Probes supplied and intended for use?

Reusable Probes are supplied as reusable instruments, meaning they are designed to be cleaned, sterilized, and used multiple times in clinical settings, as stated in the device description.

What regulatory pathway was used for Reusable Probes and when were they cleared?

Reusable Probes were cleared via the FDA 510(k) pathway under K943070 on July 22, 1994, by Surgin Surgical Instrumentation, Inc., as specified in the device data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: REUSABLE PROBES (K943070) — FDA 510 (k) | Innolitics, PDF K943070 - Reusable Probes, Explore Surgin Surgical Instrumentation Inc Parts Catalog, Explore Surgin Surgical Instrumentation Inc Parts Catalog, Buy Surgin Surgical Instrumentation Inc (CAGE Code 060S3)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Surgin Surgical Instrumentation, Inc.

Sources (1)

  • FDA 510(k) K943070 24 fields · synced Sep 25, 2026