Pruitt Irrigation and Occlusion Catheter

Q: What is the product code of K844094?

The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.

FDA 510(k) K844094 · Bionomy, Inc.

Substantially Equivalent

510(k) numberK844094

Submission

Device name: Pruitt Irrigation and Occlusion Catheter
Applicant: Bionomy, Inc.
Tampa, FL, US
Received: October 18, 1984
Decision date: November 29, 1984
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: GBX – Catheter, Irrigation
Device class: Class I (low risk)
Regulation: 21 CFR 878.4200
Specialty: General, Plastic Surgery

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K974233	Lysonix Irrigation SystemGBX · Traditional	Lysonix, Inc.	02/03/1998SE
K973703	Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional	Allegiance Healthcare Corp.	12/04/1997SE
K972635	Ultracell Suction SpongeGBX · Traditional	Ultracell Medical Technologies, Inc.	10/01/1997SE
K965146	Flat Closed Wound Drain with TrocarGBX · Traditional	Axiom Medical, Inc.	03/10/1997SE

More from Axiom Medical, Inc.

510(k)	Device	Decision
K851101	Bionomy's Multi-Lumen Central Venous Catheter-SetFOZ · Traditional	04/12/1985SE
K832023	Embolectomy CatheterDXE · Traditional	08/31/1983SE
K812111	Pruitt Arterial Occlusion Cholang. CathDYG · Traditional	11/16/1981SE
K811276	Occlusion CatheterDYG · Traditional	06/30/1981SE

Questions and answers

When was Pruitt Irrigation and Occlusion Catheter cleared by the FDA?

Pruitt Irrigation and Occlusion Catheter (K844094) received a 510(k) decision of Substantially Equivalent on November 29, 1984, 42 days after the submission was received.

What is the product code of K844094?

The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.