Who else makes this device?

Name: Sutrasilk
Brand: Sutrasilk

General & Plastic Surgery › TherapeuticSuture, Nonabsorbable, Silk

Sutrasilk

4-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specifications: CT-135-17, Cutting Tip, 3/8 circle (140 degrees), length 15.9 mm, wire 0.43mm / # of…

Registry build 21.09.26

4-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specifications: CT-135-17, Cutting Tip, 3/8 circle (140 degrees), length 15.9 mm, wire 0.43mm / # of needles: Single arm

4manufacturers in China registered for this device type

7catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Shandong (2), Shanghai (1), Beijing (1).

Chinese manufacturers registered for FDA product code GAP
Manufacturer	City	Province	Registered as	Device types
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38
Shandong Haidike Medical Products Co., Ltd.	Heze	Shandong	Manufacturer	22
Foosin Medical Supplies Inc.ltd	Weihai	Shandong	Manufacturer	8
ARC Medical Supplies (Beijing) Co., Ltd.	Beijing	Beijing	Manufacturer	7

Record

Regulatory record for Sutrasilk
Listed by	Visionary Medical Supplies, Inc., United States
FDA product code	GAP
Device type	Suture, Nonabsorbable, Silk
Device class	Class 2
Regulation	21 CFR 878.5030
Establishment	Specification developer, Manufacturer, Exporter
510(k)	K994177
Record published	2016-09-06
Record revised	2021-02-05 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Carton of 12, pouch
Sizes	Angle 140 °; outer diameter 0.2 to 0.43 mm; length 6 to 15.9 mm; length 30 to 76 cm
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Sutrasilk
Catalogue number	Size	Status
S640112	Angle 140 °	In distribution
VS84081	Length 40 cm	In distribution
S84082	Angle 140 °	In distribution
S74092	Angle 140 °	In distribution
VS84082	Angle 140 °	In distribution
S440171C	Angle 140 °	In distribution
S74092TP	Angle 140 °	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
DemeSILK	Demetech Corp.	1,198
Silkam	B Braun Surgical SA	632
Wego-Silk Non-absorbable Surgical Suture With Needle	Foosin Medical Supplies Inc.ltd	404
Sofsilk	Covidien LP	319
Perma-Hand	Ethicon, Inc.	231
Deknatel	Teleflex Medical LLC	109
Atramat	Internacional Farmacéutica S.A DE C.V	100
Mani Sutures Silk	Mani, Inc.	75
Suture, Nonabsorbable, Silk	C P Medical Inc.	48
Sutumed	Unilene S.A.C.	44
Darby Dental Supply, LLC	Darby Dental Supply, LLC	36
Silk	Resorba Medical GmbH	35

Showing 12 of 205. All products under Suture, Nonabsorbable, Silk

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K994177	2000-02-08

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
N80989	1989-08-01	SILK SUTURES	Lukens Corp.
N84348	1989-06-16	NONABSORBABLE SURG. SUTURES, BRAIDED SILK	Deknatel, Inc.
N85143	1987-04-03	SUTURES	Sharpoint, Inc.
N11397	1982-12-08	SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP	Ethicon, Inc.
N84047	1982-07-16	SILK NONABSORBABLE SUTURES, USP	Davis & Geck, 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.