Modified Servo Syringe

FDA 510(k) K881521 · Engineering, Inc.

Substantially Equivalent

510(k) numberK881521

Submission

Device name
Modified Servo Syringe
Applicant
Engineering, Inc.
Fort Lauderdale, FL, US
Received
April 8, 1988
Decision date
May 31, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXT – Injector And Syringe, Angiographic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1650
Specialty
Cardiovascular

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K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…DXT · Traditional Fortis Biosolutions Company Limited05/14/2026SE
K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…DXT · Traditional Acist Medical Systems, Inc.05/13/2026SE
K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…DXT · Traditional Acist Medical Systems, Inc.05/13/2026SE
K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeDXT · Traditional Shenzhen Maiwei Biotech Co., Ltd.04/16/2026SE
K251788Extension tubeDXT · Traditional Zhuhai DR Medical Instruments Co., Ltd.03/05/2026SE
K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…DXT · Traditional Bayer Medical Care, Inc.02/13/2026SE
K244038High Pressure TubingDXT · Traditional Shandong Int Medical Instruments Co., Ltd.09/05/2025SE
K242143Angiography InjectorDXT · Traditional Shandong Int Medical Instruments Co., Ltd.12/23/2024SE
K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)DXT · Traditional Nemoto Kyorindo Co., Ltd.08/27/2024SE
K241109Single-use Sterile High-pressure Angiographic Syringes and AccessoriesDXT · Traditional Shenzhen Boon Medical Supply Co., Ltd.08/22/2024SE

More from Shenzhen Boon Medical Supply Co., Ltd.

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K862749LS9000 Suction Biopsy NeedleGDM · Traditional 09/15/1986SE
K862476LS3000 Cannula Uterine SuctionHHI · Traditional 07/18/1986SE
K854359LM2000A Surgical Suction MonitorKDQ · Traditional 03/03/1986SE
K854844LS1000 Surgical Aspirator IIBTA · Traditional 02/12/1986SN

Questions and answers

When was Modified Servo Syringe cleared by the FDA?

Modified Servo Syringe (K881521) received a 510(k) decision of Substantially Equivalent on May 31, 1988, 53 days after the submission was received.

What is the product code of K881521?

The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.