Arthroscopic Surgical Knives Models 1001 and 1002

FDA 510(k) K903213 · Percutaneous Technologies

Substantially Equivalent

510(k) numberK903213

Submission

Device name
Arthroscopic Surgical Knives Models 1001 and 1002
Applicant
Percutaneous Technologies
Walnut, CA, US
Received
July 23, 1990
Decision date
July 27, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HEX – Colposcope (And Colpomicroscope)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1630
Specialty
Obstetrics/Gynecology

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Questions and answers

When was Arthroscopic Surgical Knives Models 1001 and 1002 cleared by the FDA?

Arthroscopic Surgical Knives Models 1001 and 1002 (K903213) received a 510(k) decision of Substantially Equivalent on July 27, 1990, 4 days after the submission was received.

What is the product code of K903213?

The FDA product code is HEX – Colposcope (And Colpomicroscope), a Class II (moderate risk) device regulated under 21 CFR 884.1630.