Who else makes this device?

Name: Surgipoint
Brand: Surgipoint

General & Plastic Surgery › SurgicalSuture, Surgical, Absorbable, Polydioxanone

Surgipoint

Catalogue number D487, listed by Riverpoint Medical LLC, United States, under Suture, Surgical, Absorbable, Polydioxanone. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Shandong (1), Beijing (1).

Chinese manufacturers registered for FDA product code NEW
Manufacturer	City	Province	Registered as	Device types
Foosin Medical Supplies Inc.ltd	Weihai	Shandong	Manufacturer	8
ARC Medical Supplies (Beijing) Co., Ltd.	Beijing	Beijing	Manufacturer	7

Record

Regulatory record for Surgipoint
Listed by	Riverpoint Medical LLC, United States
FDA product code	NEW
Device type	Suture, Surgical, Absorbable, Polydioxanone
Device class	Class 2
Regulation	21 CFR 878.4840
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Record published	2020-10-09
Record revised	2022-10-17 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Pack of 12

Catalogue Numbers

Catalogue numbers for Surgipoint
Catalogue number	Size	Status
D487		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
DemeDIOX	Demetech Corp.	994
Monoplus	B Braun Surgical SA	697
PDS	Ethicon, Inc.	430
Wego-PDO Absorbable Surgical Suture With Needle	Foosin Medical Supplies Inc.ltd	180
Stratafix	Ethicon, Inc.	172
Atramat	Internacional Farmacéutica S.A DE C.V	74
PDO Max Threads	Max Pdo Inc	64
Assufil Monofilamento	Assut Europe	50
LES Encres	Meditime Co., Ltd.	42
DemeDIOX Barbed	Demetech Corp.	40
Viola	Meditime Co., Ltd.	36
Stratafix Spiral	Surgical Specialties México, S. de R.L. de C.V.	34

Showing 12 of 292. All products under Suture, Surgical, Absorbable, Polydioxanone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K100461	2010-07-08

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2012-12-13	Class II	Employee error	Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.	1932 pieces	2013-11-21

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
N18331	1986-06-06	PDS SUTURE (DYED)	Ethicon, Inc.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.