Opticlean Lens Irrigator & Optidock Tissue Ligator

Q: What is the product code of K051700?

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) K051700 · Medchannel, LLC

Substantially Equivalent

510(k) numberK051700

Submission

Device name: Opticlean Lens Irrigator & Optidock Tissue Ligator
Applicant: Medchannel, LLC
Boston, MA, US
Received: June 24, 2005
Decision date: August 15, 2005
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
K061831	Medchannel HTS SystemIYN · Traditional	08/07/2006SE
K060494	Easytac Anchor. Easytac Delivery SystemGDW · Traditional	07/03/2006SE

Questions and answers

When was Opticlean Lens Irrigator & Optidock Tissue Ligator cleared by the FDA?

Opticlean Lens Irrigator & Optidock Tissue Ligator (K051700) received a 510(k) decision of Substantially Equivalent on August 15, 2005, 52 days after the submission was received.

What is the product code of K051700?

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