Disposable Scissors

FDA 510(k) K920297 · Falcon Instruments, Inc.

Substantially Equivalent

510(k) numberK920297

Submission

Device name
Disposable Scissors
Applicant
Falcon Instruments, Inc.
Bethesda, MD, US
Received
January 22, 1992
Decision date
September 11, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MDM – Instrument, Manual, Surgical, General Use
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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More from Denver Biomedicals, Inc.

510(k)DeviceDecision
K930775Disposable Forceps, Hemostats, Needle Guides, EtcMDM · Traditional 04/23/1993SE
K920296Disposable ForcepsMDM · Traditional 09/11/1992SE
K920298Disposable HemostatsHRQ · Traditional 08/11/1992SE

Questions and answers

When was Disposable Scissors cleared by the FDA?

Disposable Scissors (K920297) received a 510(k) decision of Substantially Equivalent on September 11, 1992, 233 days after the submission was received.

What is the product code of K920297?

The FDA product code is MDM – Instrument, Manual, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.