# K883338: Surgical Sealant Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Micromedics, Inc.
- Decided: Aug 23, 1988 after 14 days
- Product code: KYZ (Syringe, Irrigating (Non Dental))
- Device class: 1
- Regulation: 21 CFR 880.6960
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020147: Magellan Ratio Dispenser Kit/Magellan Spray Tip/Magellan Cannula Tip (2002), 1 descendant of its own
- K091722: Coaxial Applicator System (2010), 0 descendants of its own
- K041830: Magellan Ratio Dispenser Kit (2004), 0 descendants of its own

## Recalls of this device
- Mar 15, 2010 · Not classified · Z-0345-2011: Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause tran
- Nov 16, 2009 · Not classified · Z-1537-2012: This product has been recalled due to the lot number being different on the box and pouch. The lot number on the box label was incorrectly printed as 11144 instead of 111144. The pouch label reference

Source page: https://510kreport.com/device/K883338
Methodology: https://510kreport.com/methodology