510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NEWClass II

Suture, Surgical, Absorbable, Polydioxanone

21 CFR 878.4840 / General, Plastic Surgery
FDA source (opens on fda.gov)

NEW is the FDA product code for Suture, Surgical, Absorbable, Polydioxanone, a class II device type, regulated under 21 CFR 878.4840. As of , FDA records hold 66 510(k) clearances under this code, the most recent dated , and 40 recalls.

Classification record

Product code
NEW
Device name
Suture, Surgical, Absorbable, Polydioxanone
Regulation
21 CFR 878.4840
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
67
Ingested recalls
40

Clearances, product code NEW

By decision year
67 clearances under product code NEW with a decision year between 2001 and 2026, 2025 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code NEW by decision year
YearClearances
20011
20021
20034
20045
20051
20062
20072
20085
20103
20111
20123
20135
20141
20152
20163
20171
20183
20194
20203
20211
20221
20231
20243
20256
20265

Applicants with the most clearances

Product code NEW
Applicants holding the most 510(k) clearances under product code NEW
ApplicantClearances
Ethicon, Inc9
Surgical Specialties Corp5
DePuy Mitek, Inc.4
Demetech Corp.3
Feeltech Co.,Ltd.3
Hans Biomed Corp.3
Angiotech2
Cp Medical2
Foosin Medical Supplies Inc., Ltd.2
Hyundae Meditech Co., Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 75 companies shown, in name order