Keisei Scalpel (Sterile and Non-Sterile)

FDA 510(k) K863213 · Keisei Medical Industrial Co., Ltd.

Substantially Equivalent

510(k) numberK863213

Submission

Device name
Keisei Scalpel (Sterile and Non-Sterile)
Applicant
Keisei Medical Industrial Co., Ltd.
Bethel, CT, US
Received
August 20, 1986
Decision date
September 2, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GDX – Scalpel, One-Piece
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GDX

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K923689Surgistar BladesGDX · Traditional Surgistar, Inc.09/09/1992SE
K921167UltrabladeGDX · Traditional Micron Technology, Inc.07/30/1992SE
K914086Ican Cylindrical SpongesGDX · Traditional Icn Pharmaceuticals, Inc.10/09/1991SE
K904505Cci Corneal ScarifierGDX · Traditional Buckman Co., Inc.04/23/1991SE
K9053801-CUT Acl Graft KnifeGDX · Traditional Depuy, Inc.12/13/1990SE
K895682Vessel LoopsGDX · Traditional Applied Medical Technologies10/24/1989SE
K893033Mini-Diamond KnifeGDX · Traditional L.A.B. Instruments05/26/1989SE
K880028Omed Disposable ScalpelGDX · Traditional Oxboro Medical Intl., Inc.01/29/1988SE
K871894KCK Industries' Surgical InstrumentsGDX · Traditional Kck Industries06/23/1987SE
K863950P.S.I.-Disposable Metal Handle Surgeons ScalpelGDX · Traditional Precision Surgical Industries, Inc.10/24/1986SE

More from Precision Surgical Industries, Inc.

510(k)DeviceDecision
K863214Keisei Micro-Blades (Sterile and Non-Sterile)GES · Traditional 09/02/1986SE
K863212Keisei Handles for Surgical BladesGDZ · Traditional 09/02/1986SE
K863211Keisei Surgical Blades (Sterile & Non-Sterile)GES · Traditional 09/02/1986SE

Questions and answers

When was Keisei Scalpel (Sterile and Non-Sterile) cleared by the FDA?

Keisei Scalpel (Sterile and Non-Sterile) (K863213) received a 510(k) decision of Substantially Equivalent on September 2, 1986, 13 days after the submission was received.

What is the product code of K863213?

The FDA product code is GDX – Scalpel, One-Piece, a Class I (low risk) device regulated under 21 CFR 878.4800.