Surgical Aspirator

FDA 510(k) K850946 · Medicalex

Substantially Equivalent for Some Indications

510(k) numberK850946

Submission

Device name
Surgical Aspirator
Applicant
Medicalex
Paris 75013, FR
Received
March 7, 1985
Decision date
September 16, 1985
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.

510(k)DeviceDecision
K851349Lere Nail & Plate Combin. One Piece ForgedKTW · Traditional 05/29/1985SE
K833377MedicalexGEA · Traditional 09/27/1984SE
K831728MedicalexFQM · Traditional 01/09/1984SE

Questions and answers

When was Surgical Aspirator cleared by the FDA?

Surgical Aspirator (K850946) received a 510(k) decision of Substantially Equivalent for Some Indications on September 16, 1985, 193 days after the submission was received.

What is the product code of K850946?

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