# K960519: Martech Endoscopic Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Martech Medical Products, Inc.
- Decided: May 1, 1996 after 86 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820973 (1982). 2 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933815: Bard Endoscopic Injection System, C.R. Bard, Inc. (1993). Our OCR of the scanned summary read K933812, FDA’s number for Advanced Surgical, Inc. Cannula Cleaning Device and… (Advanced Surgical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bard Endoscopic Injection Needle”.
- K820973: Endoscopic Injection Needle, Mill-Rose Laboratory (1982) Summary page 1.

## Most influential descendants
- K982890: Advanced Uroscience Injection Needle (1998), 20 descendants of its own
- K990996: Genyx Medical Injection Needle (1999), 13 descendants of its own
- K022484: Cook Injection Needle (2002), 12 descendants of its own
- K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip (2009), 3 descendants of its own
- K051905: Uroplasty Rigid Endoscopic Needle (2005), 3 descendants of its own

## Indications for use
The Martech Endoscopic Injection Needle is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures. As with currently marketed endoscopic injection needles, the Martech Endoscopic Injection Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic and gastroscopic procedures; delivery of local anesthetics during cystoscopic or laryngoscopic procedures; or delivery of saline or contrast media during colonoscopic procedures.

Source page: https://510kreport.com/device/K960519
Methodology: https://510kreport.com/methodology