FFOClass I

Retractor, Self-Retaining

21 CFR 876.4730 / Gastroenterology, Urology

FFO is the FDA product code for Retractor, Self-Retaining, a class I device type, regulated under 21 CFR 876.4730. As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 1999-12-22, and 3 recalls.

Classification record

Product code: FFO
Device name: Retractor, Self-Retaining
Regulation: 21 CFR 876.4730
Device class: Class I
Review panel: Gastroenterology, Urology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 5
Ingested recalls: 3

Clearances, product code FFO

By decision year

5 clearances under product code FFO with a decision year between 1985 and 1999, 1985 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code FFO by decision year
Year	Clearances
1985	2
1986	1
1987	1
1999	1

Applicants with the most clearances

Product code FFO

Applicants holding the most 510(k) clearances under product code FFO
Applicant	Clearances
Dantec Electronics, Inc.	2
Advanced Surgical Concepts (Asc)	1
Sur-Med Instruments, Inc.	1
The Kendal Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 147 companies shown, in name order