Introcular Fluid Injector

FDA 510(k) K881707 · B&B Medical Assoc., Inc.

Substantially Equivalent

510(k) numberK881707

Submission

Device name
Introcular Fluid Injector
Applicant
B&B Medical Assoc., Inc.
Danvers, MA, US
Received
April 11, 1988
Decision date
October 21, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FIH – Pump, Infusion Or Syringe, Extra-Luminal
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

Other 510(k)s with product code FIH

510(k)DeviceApplicantDecision
K932055Percupump IIFIH · Traditional E-Z-Em, Inc.03/21/1995SE
K935461Vector Ambulatory Drug Delivery SystemFIH · Traditional Infusion Technology Intl.04/28/1994SE
K931113Cadd-Tpn(Tm) Ambulatory Infusion SystemFIH · Traditional Pharmacia Deltec, Inc.04/28/1994SE
K900439Single-Use, Sterile, Prefilled Syringe, 60CCFIH · Traditional L H M Ent., Inc.02/15/1990SE

More from L H M Ent., Inc.

510(k)DeviceDecision
K881519Vac-G (Guillotine Vitrector)HQE · Traditional 09/08/1988SE
K881520Vac (Oscillating Vitrector)HQE · Traditional 09/07/1988SE
K881518Infusion HandleKYG · Traditional 08/22/1988SE
K881517B & B I/A HandpieceKYG · Traditional 08/22/1988SE

Questions and answers

When was Introcular Fluid Injector cleared by the FDA?

Introcular Fluid Injector (K881707) received a 510(k) decision of Substantially Equivalent on October 21, 1988, 193 days after the submission was received.

What is the product code of K881707?

The FDA product code is FIH – Pump, Infusion Or Syringe, Extra-Luminal, a Class II (moderate risk) device regulated under 21 CFR 876.5820.