Skip to content

Surgitek Medical Engineering Corp.

United StatesFDA applicant, unverified

Devices
11

What Surgitek Medical Engineering Corp. makes

Surgitek Medical Engineering Corp. manufactures surgical and diagnostic instruments for urology, gastroenterology, and endoscopy, including stone retrieval baskets, grasping and biopsy forceps, ERCP catheters, ureteral stents, cytology brushes, infusion guidewires, and sclerotherapy needles. Their portfolio also includes contrast media systems for ERCP procedures and laparoscopic cholangiogram kits, designed for minimally invasive interventions.

The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

Search and filter all 11 devices
Skip device list

  • Stone Basket Ref K914505

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Grasping Forceps Ref K914503

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Biopsy Forceps Ref K914497

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • E.R.C.P. Catheter Ref K914495

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitek(R) Turp Monitor Ref K903127

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitek(R) 4.5Fr Lubri-Flex(Tm) Ureteral Stent Ref K913928

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cytology Brush Ref K914504

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitek(R) Ercp Contrast Media System Ref K910769

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sclerotherapy Needle Ref K914496

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitek(R) 420 Cm G.I. Infusion Guidewire Ref K910768

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgitek(R) Laparoscopic Cholangiogram Kit Ref K913294

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-11 of 11

Frequently asked questions

How many devices does Surgitek Medical Engineering Corp. have in the registry?

The registry currently lists 11 devices for Surgitek Medical Engineering Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Surgitek Medical Engineering Corp.'s devices?

Among its 11 most recently registered devices, Surgitek Medical Engineering Corp. has devices listed in FDA 510(k) (11 devices).

What risk classes do Surgitek Medical Engineering Corp.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Surgitek Medical Engineering Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Surgitek Medical Engineering Corp. in the registry?

The most recently registered devices listed for Surgitek Medical Engineering Corp. include STONE BASKET, GRASPING FORCEPS, BIOPSY FORCEPS and E.R.C.P. CATHETER.

Generated automatically from registry data and not verified by a human reviewer.