LS1000 Surgical Aspirator II

FDA 510(k) K854844 · Engineering, Inc.

Substantially Equivalent for Some Indications

510(k) numberK854844

Submission

Device name
LS1000 Surgical Aspirator II
Applicant
Engineering, Inc.
Foster City, CA, US
Received
December 4, 1985
Decision date
February 12, 1986
Decision
Substantially Equivalent for Some Indications (SN)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BTA – Pump, Portable, Aspiration (Manual Or Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

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More from Shenzhen Kingboom Technology Co., Ltd.

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K881521Modified Servo SyringeDXT · Traditional 05/31/1988SE
K862749LS9000 Suction Biopsy NeedleGDM · Traditional 09/15/1986SE
K862476LS3000 Cannula Uterine SuctionHHI · Traditional 07/18/1986SE
K854359LM2000A Surgical Suction MonitorKDQ · Traditional 03/03/1986SE

Questions and answers

When was LS1000 Surgical Aspirator II cleared by the FDA?

LS1000 Surgical Aspirator II (K854844) received a 510(k) decision of Substantially Equivalent for Some Indications on February 12, 1986, 70 days after the submission was received.

What is the product code of K854844?

The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.