510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KGSClass I

Retention Device, Suture

21 CFR 878.4930 / General, Plastic Surgery
FDA source (opens on fda.gov)

KGS is the FDA product code for Retention Device, Suture, a class I device type, regulated under 21 CFR 878.4930. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KGS
Device name
Retention Device, Suture
Regulation
21 CFR 878.4930
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
20
Ingested recalls
2

Clearances, product code KGS

By decision year
20 clearances under product code KGS with a decision year between 1977 and 2003, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KGS by decision year
YearClearances
19771
19791
19811
19821
19841
19861
19871
19881
19893
19902
19912
19931
19951
19971
20021
20031

Applicants with the most clearances

Product code KGS
Applicants holding the most 510(k) clearances under product code KGS
ApplicantClearances
Acufex Microsurgical, Inc.4
Concept, Inc.2
Ethicon, Inc2
Accu-Speed, Incorporated1
Aesculap Inc1
Zimmer GmbH1
Dermacare1
Edwards Orthopaedics Div., Baxter Healthcare Corp.1
Mitek Surgical Products, Inc.1
Richard'S Medical Equip., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 73 companies shown, in name order