Multiple Purpose Forceps

FDA 510(k) K924792 · Nusurg, Inc.

Substantially Equivalent

510(k) numberK924792

Submission

Device name
Multiple Purpose Forceps
Applicant
Nusurg, Inc.
Cincinnati, OH, US
Received
September 23, 1992
Decision date
April 28, 1994
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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Questions and answers

When was Multiple Purpose Forceps cleared by the FDA?

Multiple Purpose Forceps (K924792) received a 510(k) decision of Substantially Equivalent on April 28, 1994, 582 days after the submission was received.

What is the product code of K924792?

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