Cryoseal FS Applicator System

Q: What is the product code of K071126?

The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.

FDA 510(k) K071126 · Thermogenesis Corp.

Substantially Equivalent

510(k) numberK071126

Submission

Device name: Cryoseal FS Applicator System
Applicant: Thermogenesis Corp.
Rancho Cordova, CA, US
Received: April 23, 2007
Decision date: August 16, 2007
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FMF – Syringe, Piston
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5860
Specialty: General Hospital

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K253747	Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional	Jiangsu Enjosim Medical Technology Co., Ltd.	08/14/2026SE
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K253112	Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special	Hlb Lifescience Co., Ltd.	05/21/2026SE
K252279	Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional	Chirana T.Injecta,A.S.	04/17/2026SE
K253068	Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional	CMT Health PTE., Ltd.	02/23/2026SE
K253769	Instylla Delivery KitFMF · Special	Instylla, Inc.	12/22/2025SE

More from Instylla, Inc.

510(k)	Device	Decision
K081345	Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)JQC · Abbreviated	07/10/2008SN
K955282	Thermogenesis Drop Applicator, Kits, Spray Kits and TipsFMF · Traditional	05/06/1996SE

Questions and answers

When was Cryoseal FS Applicator System cleared by the FDA?

Cryoseal FS Applicator System (K071126) received a 510(k) decision of Substantially Equivalent on August 16, 2007, 115 days after the submission was received.

What is the product code of K071126?

The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.