Infusion Handle

FDA 510(k) K881518 · B&B Medical Assoc., Inc.

Substantially Equivalent

510(k) numberK881518

Submission

Device name
Infusion Handle
Applicant
B&B Medical Assoc., Inc.
Danvers, MA, US
Received
April 11, 1988
Decision date
August 22, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KYG – Device, Irrigation, Ocular Surgery
Device class
Class I (low risk)
Regulation
21 CFR 886.4360
Specialty
Ophthalmic

Other 510(k)s with product code KYG

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K010353Med-Logics Disposable Alk TubingKYG · Traditional Med-Logics, Inc.04/27/2001SE
K003036Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model…KYG · Traditional Retinalabs.Com12/22/2000SE
K993591Bladeworks Disposable Alk TubingKYG · Traditional Blade Works, Inc.12/28/1999SE
K981116Sovereign Cataract Extraction SystemKYG · Traditional Allergan, Inc.05/19/1998SE
K980647Eye Irrigator Model #2020KYG · Traditional Eye-Deal Ocular Safety Products, Inc.05/15/1998SE
K974561Moistair Fluid Air Tubing SetKYG · Traditional American Medical Devices, Inc.02/19/1998SE
K971173ML Disposable Alk TubingKYG · Traditional Med-Logics, Inc.05/22/1997SE
K970161Hedges Corneal Wetting PakKYG · Traditional Hedges Cwp, Inc.03/25/1997SE
K954842D.O.R.C. Vfi/Vfe SystemKYG · Traditional Dutch Ophthalmic USA, Inc.04/15/1996SE
K945171Disposable & Resuable Irrigation/Aspiration HandpieceKYG · Traditional Boston Surgical Products, Inc.02/08/1995SE

More from Boston Surgical Products, Inc.

510(k)DeviceDecision
K881707Introcular Fluid InjectorFIH · Traditional 10/21/1988SE
K881519Vac-G (Guillotine Vitrector)HQE · Traditional 09/08/1988SE
K881520Vac (Oscillating Vitrector)HQE · Traditional 09/07/1988SE
K881517B & B I/A HandpieceKYG · Traditional 08/22/1988SE

Questions and answers

When was Infusion Handle cleared by the FDA?

Infusion Handle (K881518) received a 510(k) decision of Substantially Equivalent on August 22, 1988, 133 days after the submission was received.

What is the product code of K881518?

The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.