Endopath Tissue Retaining Component

FDA 510(k) K923679 · Ethicon Endo-Surgery, Inc.

Substantially Equivalent

510(k) numberK923679

Submission

Device name
Endopath Tissue Retaining Component
Applicant
Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US
Received
July 22, 1992
Decision date
September 9, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KCJ – Applicator, Ent
Device class
Class I (low risk)
Regulation
21 CFR 874.5220
Specialty
Ear, Nose, Throat

Other 510(k)s with product code KCJ

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K921053Laparomed Ligating LoopKCJ · Traditional Laparomed Corp.08/06/1992SE
K894369Apdyne Phenol Applicator KitKCJ · Traditional Apdyne Medical Co.10/12/1989SESD
K832667Lucae's Ear & Nasal ApplicatorsKCJ · Traditional Kells Medical, Inc.09/29/1983SE

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Questions and answers

When was Endopath Tissue Retaining Component cleared by the FDA?

Endopath Tissue Retaining Component (K923679) received a 510(k) decision of Substantially Equivalent on September 9, 1992, 49 days after the submission was received.

What is the product code of K923679?

The FDA product code is KCJ – Applicator, Ent, a Class I (low risk) device regulated under 21 CFR 874.5220.