# K052695: Suretek Medical Reprocessed Arthroscopic Blades and Burs

- Pathway: 510(k) (Traditional)
- Applicant: Suretek Medical
- Decided: May 10, 2006 after 224 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K862807 (1986). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953695: Dyonics Disposable Arthroscopic Blades, Smith & Nephew Dyonics, Inc. (1995) Summary page 1.
- K941333: SE5 Arthroscopy Sytem, Stryker Endoscopy (1994) Summary page 1.
- K990524: E9000 System, Linvatec Corp. (1999) Summary page 1.
- K012346: Vanguard Reprocessed Arthroscopic Blades, Vanguard Medical Concepts, Inc. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K010667: Gambro Polyflux 24S, Gambro Polyflux 24R, Gambro Renal Products (2001). Our reading of the summary gave K010667, FDA’s number for Gambro Polyflux 24S, Gambro Polyflux 24R (Gambro Renal Products). Its FDA name has none of the distinctive words the summary uses for the device it names, “Xomed (Medtronic)”. Kept off the family tree. Summary page 1.
- K012667: Reprocessed Arthroscopic Shapers, Surgical Instruments Service and Savings, Inc. (2002). Our reading of the summary gave K012667, FDA’s number for Reprocessed Arthroscopic Shapers (Surgical Instruments Service and Savings, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “MediSISS”. Kept off the family tree. Summary page 1.

## Indications for use
SureTek Reprocessed Arthroscopic Blades and Burs are intended for use during arthroscopic and endoscopic procedures for cutting and resection of soft tissue, cartilage and bone. Endoscopic sinus surgery is limited to small diameter instruments (2 to 3.5 mm).

Source page: https://510kreport.com/device/K052695
Methodology: https://510kreport.com/methodology