VLOC9ABSORBABLE Wound Closure Device

Q: What is the product code of K100257?

The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.

FDA 510(k) K100257 · Surgical Devices, A Division of Tyco Healthcare

Substantially Equivalent

510(k) numberK100257

Submission

Device name: VLOC9ABSORBABLE Wound Closure Device
Applicant: Surgical Devices, A Division of Tyco Healthcare
North Haven, CT, US
Received: January 28, 2010
Decision date: May 10, 2010
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4493
Specialty: General, Plastic Surgery
Implant: Yes

Other 510(k)s with product code GAM

510(k)	Device	Applicant	Decision
K253394	Coated VICRYL (Polyglactin 910) Plus Antibacterial SutureGAM · Traditional	ETHICON, Inc.	06/25/2026SE
K253530	Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional	Medtronic	05/28/2026SE
K253852	MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic…GAM · Traditional	ETHICON, Inc.	02/06/2026SE
K252743	STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL…GAM · Traditional	ETHICON, Inc.	12/22/2025SE
K253620	TroClose 1200GAM · Special	Gordian Surgical, Ltd.	12/16/2025SE
K252820	PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90…GAM · Special	Internacional Farmacéutica S.A DE C.V	10/03/2025SE
K233265	Monotime and Optime RGAM · Abbreviated	Peters Surgical	10/11/2024SE
K232372	Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)GAM · Abbreviated	Peters Surgical	07/12/2024SE
K221527	StitchKitGAM · Traditional	Origami Surgical Inc .	02/14/2023SE
K221744	STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceGAM · Traditional	ETHICON, Inc.	11/15/2022SE

More from ETHICON, Inc.

510(k)	Device	Decision
K100242	Auto Suture Endo Clip III5MM Clip AdapterFZP · Special	02/17/2010SE
K093408	V-Loc 180 Absorbable Wound Closure DeviceGAM · Special	11/12/2009SE

Questions and answers

When was VLOC9ABSORBABLE Wound Closure Device cleared by the FDA?

VLOC9ABSORBABLE Wound Closure Device (K100257) received a 510(k) decision of Substantially Equivalent on May 10, 2010, 102 days after the submission was received.

What is the product code of K100257?

The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.