Who else makes this device?

Name: Wego-Pgcl Absorbable Surgical Suture With Needle
Brand: Wego-Pgcl Absorbable Surgical Suture With Needle

Wego-Pgcl Absorbable Surgical Suture with Needle · Suture, Absorbable, Synthetic, Polyglycolic Acid → General & Plastic Surgery

The WEGO-PGCL suture with needle is a synthetic absorbable monofilament for bringing soft tissues together or tying off tissue. It is not intended for cardiovascular or neurological procedures. The thread is made from a copolymer of glycolide and caprolactone.

A stainless steel needle carries the suture through tissue during placement. The material is available dyed violet or undyed, with different thread sizes, lengths and needle forms supplied for the selected procedure.

Supply and Handling

The suture and needle assembly is supplied sterile following ethylene oxide sterilization and is intended for single use. The absorbable thread remains at the repair or ligation site after the needle has been used to place it.

4manufacturers in China registered for this device type

93catalogue numbers in this listing

5510(k) clearances naming this product code

Who Else Makes It

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

Chinese manufacturers registered for FDA product code GAM
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Foosin Medical Supplies Inc.ltd	Weihai	Shandong	Manufacturer	8
ARC Medical Supplies (Beijing) Co., Ltd.	Beijing	Beijing	Manufacturer	7
Sichuan Innovation Technology Co., Ltd.	Chengdu	Sichuan	Contract manufacturer	2

Record

Regulatory record for Wego-Pgcl Absorbable Surgical Suture With Needle
Listed by	Foosin Medical Supplies Inc.ltd, China
FDA product code	GAM
Device type	Suture, Absorbable, Synthetic, Polyglycolic Acid
Device class	Class 2
Regulation	21 CFR 878.4493
Establishment	Manufacturer
510(k)	K142810
Record published	2016-04-14
Record revised	2021-09-20 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Pack of 12
Distribution end date	2021-09-02
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Wego-Pgcl Absorbable Surgical Suture With Needle
Catalogue number	Size	Status
Q51123		In distribution
Q11402		In distribution
Q11262		Withdrawn
Q21262V		Withdrawn
Q11222		Withdrawn
Q31262V		Withdrawn
Q44193		Withdrawn
Q43193V		Withdrawn
Q31172		Withdrawn
Q33243V		Withdrawn
Q53193		Withdrawn
Q41222V		Withdrawn
Q21362V		Withdrawn
Q41193		Withdrawn
QB1362V		Withdrawn
Q11262HV		Withdrawn
Q63202		Withdrawn
Q33262		Withdrawn
Q63123		Withdrawn
Q13362V		Withdrawn
Q33263		Withdrawn
QB1262		Withdrawn
Q33243		Withdrawn
Q43132		Withdrawn
Q11302		Withdrawn
QB3362		Withdrawn
Q41192		Withdrawn
Q21262		Withdrawn
Q13373		Withdrawn
Q43163		Withdrawn
QB1482		Withdrawn
Q31222		Withdrawn
Q53133		Withdrawn
Q63133		Withdrawn
Q53163		Withdrawn
Q47173		Withdrawn
Q63193		Withdrawn
Q61172V		Withdrawn
Q36193		Withdrawn
QB1402H		Withdrawn
Q33192		Withdrawn
Q41202		Withdrawn
QB7362		Withdrawn
Q11362		Withdrawn
QB009001		Withdrawn
Q33173		Withdrawn
Q23263V		Withdrawn
Q41172		Withdrawn
Q11402H		Withdrawn
Q41162		Withdrawn
Q43192		Withdrawn
Q33600		Withdrawn
Q24500		Withdrawn
Q26243		Withdrawn
Q26243V		Withdrawn
Q21302V		Withdrawn
Q23263		Withdrawn
Q23600		Withdrawn
Q23243		Withdrawn
Q31222V		Withdrawn
Q31302V		Withdrawn
Q43183V		Withdrawn
Q36243		Withdrawn
Q43133		Withdrawn
Q31172V		Withdrawn
Q13372		Withdrawn
Q11362V		Withdrawn
Q11482		Withdrawn
Q21362		Withdrawn
Q21312V		Withdrawn
Q37173		Withdrawn
Q13372V		Withdrawn
Q33263V		Withdrawn
Q63132		Withdrawn
Q33283		Withdrawn
Q31262		Withdrawn
Q33172		Withdrawn
Q31362		Withdrawn
Q36243V		Withdrawn
QB3302		Withdrawn
Q43263		Withdrawn
Q33202		Withdrawn
Q43202		Withdrawn
Q33383		Withdrawn
Q51122		Withdrawn
Q43193		Withdrawn
Q33193		Withdrawn
Q41192V		Withdrawn
Q21402		Withdrawn
Q33193V		Withdrawn
Q56133		Withdrawn
Q43243		Withdrawn
Q53163V		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Novosyn	B Braun Surgical SA	2,286
DemeCRYL	Demetech Corp.	2,092
DemeSORB	Demetech Corp.	1,625
Safil	B Braun Surgical SA	1,613
Monosyn	B Braun Surgical SA	1,096
E-Pack	Ethicon, Inc.	967
Coated Vicryl	Ethicon, Inc.	933
DemeQUICK	Demetech Corp.	732
Polysorb	Covidien LP	732
DemeCAPRONE	Demetech Corp.	707
Wego-PGA Absorbable Surgical Suture With Needle	Foosin Medical Supplies Inc.ltd	554
Safil Quick+	B Braun Surgical SA	414

Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K183004	2019-01-28
K183001	2019-01-28
K142810	2014-11-14
K130737	2014-01-14
K130735	2014-01-14

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
P840051	1989-06-07	MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU	Davis & Geck, Inc.
N18387	1987-06-18	PDS(TM) SUTURE (CLEAR)	Ethicon, Inc.
N16881	1981-12-04	DEXON	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.

Wego-Pgcl Absorbable Surgical Suture With Needle