# K974815: Manan (TM) Introducer Sheath/Needle

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Jan 9, 1998 after 17 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- 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 K961216 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961216: Manan Introducer Shealth/Needle, Manan Medical Products, Inc. (1996) Summary page 1.

## Indications for use
The Manan™ Introducer Sheath/Needle is for the introduction of a .038 in. guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.

Source page: https://510kreport.com/device/K974815
Methodology: https://510kreport.com/methodology