Abdominal Spatula

FDA 510(k) K890374 · Kinetic Medical Products

Substantially Equivalent

510(k) numberK890374

Submission

Device name
Abdominal Spatula
Applicant
Kinetic Medical Products
Erie, PA, US
Received
January 23, 1989
Decision date
February 3, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GAF – Spatula, Surgical, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GAF

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K023688Lemaitre Vascular Disposable Vein StripperGAF · Traditional LeMaitre Vascular, Inc.01/30/2003SE
K935357Snap Reciprocating SawGAF · Traditional Surgiquip, Inc.01/28/1994SE
K882793PMT Fukushima Microsurgical Instrument LineGAF · Traditional Pmt Corp.07/18/1988SE
K822108Cement-PickGAF · Traditional Bio-Blitz, Inc.08/11/1982SE

More from Bio-Blitz, Inc.

510(k)DeviceDecision
K890385Midwifery/Obstetrical ForcepsHDA · Traditional 03/01/1989SE
K890387Malleable Placenta CuretteHEX · Traditional 02/27/1989SE
K890382Compression ForcepsHFW · Traditional 02/27/1989SE
K890380Cervical Biopsy ForcepsHFB · Traditional 02/27/1989SE
K890376Vaginal SpeculumHFD · Traditional 02/27/1989SE
K890383Hysterectomy ForcepsHCZ · Traditional 02/16/1989SE
K890216Microsurgical KeratomeGZX · Traditional 02/16/1989SE
K890389Umbilical ScissorsHDJ · Traditional 02/13/1989SE
K890388Cephalotomy ScissorsKNB · Traditional 02/13/1989SE
K890386Placenta and Ovum ForcepsHCZ · Traditional 02/13/1989SE

Questions and answers

When was Abdominal Spatula cleared by the FDA?

Abdominal Spatula (K890374) received a 510(k) decision of Substantially Equivalent on February 3, 1989, 11 days after the submission was received.

What is the product code of K890374?

The FDA product code is GAF – Spatula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.