Look Collagen Spacers, Model 1514B

Q: What is the product code of K001765?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.

FDA 510(k) K001765 · Surgical Specialties Corp

Substantially Equivalent

510(k) numberK001765

Submission

Device name: Look Collagen Spacers, Model 1514B
Applicant: Surgical Specialties Corp
Reading, PA, US
Received: June 12, 2000
Decision date: September 7, 2000
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: KXK – Source, Brachytherapy, Radionuclide
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.5730
Specialty: Radiology
Implant: Yes

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K223465	RadianceTx Radionuclide Brachytherapy SourceKXK · Traditional	Radiance Therapeutics, Inc.	01/11/2023SE
K221539	GammaTileKXK · Traditional	Gt Medical Technologies	11/09/2022SE
K202267	Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional	Isoray Medical, Inc.	12/31/2020SE
K193602	LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceKXK · Special	Lv Liberty Vision Corporation	05/29/2020SE
K190839	GammaTileKXK · Traditional	Gt Medical Technologies	01/23/2020SE
K191324	CivaDermKXK · Traditional	Civatech Oncology, Inc.	09/20/2019SE
K190296	GammaTileKXK · Special	Gt Medical Technologies	03/13/2019SE
K180515	GammaTileKXK · Traditional	Isoray Medical, Inc.	07/06/2018SE

More from Isoray Medical, Inc.

510(k)	Device	Decision
K160744	LOOK PTFE SutureNBY · Traditional	07/13/2016SE
K141778	Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignGAM · Special	07/30/2014SE
K141625	Polysyn Surgical SutureGAM · Special	07/18/2014SE
K141558	Quill Monoderm Knotless Tissue-Closure DeviceGAM · Special	07/11/2014SE
K140227	Monoderm Surgical SutureGAM · Special	02/28/2014SE
K080985	Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)NEW · Special	04/23/2008SE
K080680	Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneNEW · Special	03/21/2008SE
K071989	Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialNEW · Traditional	08/06/2007SE
K072028	Quill Self-Retaining System (SRS) Comprised of MonodermGAM · Traditional	08/03/2007SE
K063680	Sharpoint Pdo (Polydioxanone) SuturesNEW · Traditional	05/09/2007SE

Questions and answers

When was Look Collagen Spacers, Model 1514B cleared by the FDA?

Look Collagen Spacers, Model 1514B (K001765) received a 510(k) decision of Substantially Equivalent on September 7, 2000, 87 days after the submission was received.

What is the product code of K001765?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.